New Chemical Gets Fast-Tracked by FDA to Treat Moderate to Severe Chronic Pain

New Chemical Gets Fast-Tracked by FDA to Treat Moderate to Severe Chronic Pain

By Staff

The maker of NKTR-181, an opioid analgesic, has released results from the SUMMIT-07 Phase 3 efficacy study of the drug, which is a new chemical entity that is a full mu-opioid agonist molecule designed to provide potent pain relief without the high or addiction concerns seen with standard opioids.

Nektar Therapeutics announced that the FDA has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.

“The data from this efficacy study are extremely important because they demonstrate that NKTR-181 produces strong analgesia in patients suffering from chronic pain while NKTR-181 has also demonstrated significantly lower abuse potential than oxycodone in a human abuse potential study,” said clinical investigator Martin Hale, M.D., medical director of Gold Coast Research. “While standard opioid analgesics, including abuse-deterrent formulations, have been the most effective way to treat chronic pain, they are associated with serious safety concerns and many opioid-naïve patients fear taking them because of the potential for abuse and addiction.  The data for NKTR-181 suggest that it is a transformational pain medicine that could fundamentally change how we treat patients with chronic pain conditions.”

The following details regarding the study were provided by the company in a news release.

The SUMMIT-07 study compared twice-daily dosing of NKTR-181 tablets to placebo in the treatment of over 600 patients with moderate to severe chronic low back pain who were new to opioid therapy (opioid-naïve). The clinical trial met the primary efficacy endpoint of the study in demonstrating significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019). Key secondary endpoints of the study were also met with high statistical significance.

The Phase 3 SUMMIT-07 study used an enriched-enrollment randomized withdrawal (EERW) trial design in patients with moderate to severe chronic low back pain. The trial included an open-label titration period in which patients were titrated to a tolerated, effective dose of NKTR-181 (100 mg to 400 mg twice-daily). Following this open-label titration period, patients entered a double-blind, placebo-controlled treatment period in which they were randomized 1:1 to either continue to receive the tolerated, effective dose of NKTR-181 or to receive matching placebo (i.e. active drug was withdrawn) for a period of 12 weeks.

During the open-label titration period of the trial in which patients were titrated to a tolerated, effective dose of NKTR-181, average pain scores dropped by 65% (from 6.73 at screening to 2.32 at randomization, n=610).

The primary endpoint of the study was mean change in the weekly average pain score in the double-blind randomized treatment period from baseline (end of open-label titration period) to week 12 (end of double-blind randomized treatment period).

Primary and key sensitivity analyses:

During the double-blind randomized treatment period of the trial, average pain scores increased more in the placebo arm versus NKTR-181 at week 12 from randomization baseline (1.46, placebo versus 0.92, NKTR-181, p=0.0019, n=610).

83% of patients completed the 12-week double-blind randomized treatment period and for these study completers, average pain scores increased more in the placebo arm versus NKTR-181 at week 12 from baseline (1.25, placebo versus 0.56, NKTR-181, p < 0.0001, n=504).

Key secondary endpoints:

A statistically significant proportion of patients on NKTR-181 experienced pain reductions greater than 30% compared to placebo (71.2% versus 57.1%; p=0.0003).

A statistically significant proportion of patients on NKTR-181 experienced pain reductions greater than 50% compared to placebo (51.1% versus 37.9%; p=0.001).

A statistically significant proportion of patients on NKTR-181 reported their general overall status and quality of life as “improved” or “very much improved” compared to placebo as assessed by the Patient’s Global Impression of Change (PGIC) of pain medication questionnaire (51.5% versus 33.2%; p < 0.0001).

The study also demonstrated that NKTR-181 had a favorable safety profile and was well tolerated. During the double-blind randomized treatment period, the most commonly reported adverse events for patients ( > 5%) were nausea (10.4%) and constipation (8.7%) in the NKTR-181 arm as compared to nausea (6.0%) and constipation (3.0%) in the placebo arm.

Patients randomized to NKTR-181 as compared to placebo reported more favorable sleep outcomes as measured by the validated Medical Outcomes Study (MOS) Sleep Scale, which captures debilitating aspects of sleep most strongly associated with chronic pain.  Patients reported better overall quality of sleep with less sleep problems on NKTR-181 versus placebo. There were no differences in daytime sleepiness on NKTR-181 versus placebo.

Full data from the SUMMIT-07 study will be presented at a medical meeting in the second half of 2017.

“As a new molecule, NKTR-181 has a highly differentiated profile with the potential to be one of the most important advancements in pain medicine,” said Howard W. Robin, President and CEO of Nektar Therapeutics. “Given the seriousness of the current opioid epidemic in the U.S. and the significant number of people battling chronic pain, we are committed to bringing this new molecule to patients and physicians as quickly as possible.”

In March 2017, results from a separate human abuse potential trial of NKTR-181 were published in the American Academy of Pain Medicine’s journal of Pain Medicine. The human abuse potential study assessed the relative abuse potential of a range of therapeutic doses of NKTR-181 (100 mg to 400 mg), the same dose range evaluated in the Phase 3 SUMMIT-07 efficacy trial.  All doses of NKTR-181 tested for abuse potential were rated similarly to placebo in “drug liking” and “feeling high” scores and had highly statistically significant lower “drug liking” scores and reduced “feeling high” scores as compared to 40 mg oxycodone (p < 0.0001).  In addition, all doses of NKTR-181 also scored lower on sleepiness when compared to 40 mg oxycodone (p < 0.0001).

“It is clear that there is a pressing societal need for better and safer analgesics,” said Dr. Jack Henningfield, Ph.D., Adjunct Professor of Behavioral Biology in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine and Head of Health Policy and Abuse Liability at Pinney & Associates in Bethesda, MD. “In the human abuse potential study, even the highest analgesic dose of NKTR-181 was barely distinguishable from placebo with respect to both drug-liking and feeling high and these effects were modest compared to those produced by oxycodone.  Drug-liking and feeling high are two of the most important metrics that help us understand the abuse potential of a medicine.  Importantly, as NKTR-181 is a new chemical entity, the properties of NKTR-181 are inherent to its molecular structure and independent of any abuse-deterrent formulation.  Today’s reported efficacy and safety results, along with the human abuse potential data published this past week in Pain Medicine, suggest NKTR-181 may be a major advance towards safer opioid therapy for the treatment of moderate to severe chronic pain.”

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Authored by: Staff

There are 29 comments for this article
  1. Tim Mason at 3:57 pm

    Dr. Langley, I think if one digs deep enough they will find the addiction business lining the pockets of politicians with money via lobbying in order to get chronic pain patients classified as “addicts”. This would then lead the “Addiction Centers of America” being able to get in on the “Insurance Train”. If they happens their price and profits and total revenue go way up.
    Only a person with chronic pain understands what chronic pain feels like.
    People don’t understand if they have not experienced it first hand.
    And for someone to discount your pain that does not have it is like the embalmer at a funeral home saying, ” I know what it feels like to be dead, I work at a funeral home” Total BS.
    You are spot on in your opinion of the so called opioid epidemic. It is an opiate epidemic, cheap heroin.
    I am sick and tired of people on talk shows and fake articles showing a spilled bottle of 7.5 mg Percocet, a pile of powder and an insulin syringe full of amber liquid.
    All propaganda by the addiction business.

  2. Michael G Langley, MD at 8:46 am

    Tim,

    Doctors have said that about aspirin for decades!

    John S,

    I too am hoping that they can get good results out of this new molecule. It would mean the end of suffering for a heck of a lot of chronic pain patients, if it will be affordable!? We agree about the poorly written article.

  3. Tim Mason at 8:44 pm

    Acetylsalicylic acid (aspirin) has so many side effects I doubt FDA would approve it for use if it were just invented today.
    Just say’n

  4. Tim Mason at 8:37 pm

    John, it is Heroin (an opiate) killing people in mass, not opioid medications. Sure there are stupid people that drink liquor and take pain pills and valium or Xanax but they do this mainly with stolen prescriptions.
    It is pure conjecture to draw a vector from prescription pain medications to heroin use.
    Sort of like saying “It’s gasoline that causing drunk driving”-Ban Gasoline.

  5. Tim Mason at 11:22 am

    John, It was me that said “tell no one”. I know a girl that worked as a vet tech. She was a chronic pain patient. She told one of her coworkers about her condition and what medication she was taking. Bottom line, the girl called in sick or FMLA due to increased pain. One of her jealous coworkers told the boss she was taking morphine sulfate was obviously high at home that day. The Chronic pain patient was fired.
    Do not tell your employer anything.

  6. John S at 10:17 am

    I am not a chemist but I do have a general idea of how opiate pain medication works. These drugs promote a feeling of euphoria and a general sense of – I FEEL HAPPY – these feelings help patients to think less of pain and this allows pain reduction. Other CNS reactions are instilled by Opiates on the patients pain and they all work in unison to perceive a feeling of pain reduction. No single medication has proven to eliminate pain by 100%

    NKTR-181 makes the claim that one of its major positive attribute is the elimination of the Euphoric or “drug liking” and “feeling high” scores and had highly statistically significant lower “drug liking” scores and reduced “feeling high” scores as compared to 40 mg oxycodone “. Would this effect or lack of effect make this a better drug for pain patients or a better drug for the Anti Opiate gang ? If what makes Opiate medication work for pain patients is absent in NKTR-181 I believe this new drug cant be as effective as Opiates for patients that suffer from severe acute chronic pain. That being said – If left with no other solution and Opiates had been removed from the table then I truly hope that NKTR-181 would help my pain enough for me to continue living a productive and happy life.

    Stock Alert ! NEKTAR the maker of NKTR-181 is on the list of “Stocks to buy”. If this drug enters the market we could see a lot money made by anyone willing to invest. After all, isn’t it about money at the end of the day ? Perdue made Billions when Oxycontin came out.

    One of the most written about ( Lie ) is that long term use of Opiates has shown to be of no use for treating long term chronic pain. I think that most of us using this site do not agree with that sentiment. Another disturbing article made the claim that there are no REAL chronic pain patients making a fuss about the new guidelines, its all done through sites like the National Pain Foundation and others. The claim was made that these groups receive millions of dollars from big Pharma and therefore lack any legitimacy. I had to respond just to add that I had not seen a single dime of those millions.

    Thanks,

    John S

  7. john s at 9:16 am

    I saw mostly a – Anti Opiate scare notice that was bias and filled with opinion not fact.

    What upsets me the most is even sftill ” Opiate medication is not effective when treating long term chronic pain “. I have never read or heard of anyone that has done an article that features a patient that is helped by Opiates over a long period of time, So no one is even trying to get the ” other side ” of the story.

    Thanks,

    John S

  8. Michael G Langley, MD at 12:18 pm

    John S,

    I found the article depressingly full of the drug warriors lingo. They talked about much of the increase being opiates used as medicine, but the graphs seemed to tell a different story. The big jump seemed to be the more recent increase in heroin/Fentanyl overdoses. They failed to explain that the Fentanyl was clandestinely manufactured as well. It has all of the same risks of not knowing the dose, along with any impurities that could be present in it. The Fentanyl was represented as medical grade! It is not. One thing it is is much more deadly since the dose is usually in micro-grams. Does that make it “highly addictive” or more prone to abuse? So many things were looking like the typical drug warrior rag diatribe. If something is addictive, it is addictive,. It does not matter whether you are hooked on codeine or morphine (heroin = diacetyl-morphine) you have a complex psychological problem linked to the obsessive over-use of the opiate. It is not just dependence, which is what many chronic pain patients live with. They refused to talk about the reason that Percocette is not really a good drug for abusers. I don’t know many doctors that were treating pain with Vicodin, either! The Tylenol load that is caused by even a dose of eight tablets ad day is in the range of being toxic to the liver. The article had many parts that sounded like propaganda. But, the papers in the box at the end of the article were eye openers. They discussed the real problems and causes with a realistic evaluation. None of this should have anything to do with people that are not abusers. I would tend to say that is 98% of us chronic pain sufferers. The real problem is the science of addiction. The criminal aspects of the behavior of obsessive overuse of drugs seems to be the result. Could this not be solved by supplying the small amount of safe diacetyl-morphine to the addicts, so they don’t have to steal to supply the need. The amount of money is nothing compared to multi-trillions of dollars in our countries’ budgets. Drug abuse counseling could result in the changes that the “War on Drugs” has not! It is obvious that a big proportion, of the true drug addicts, have a mental disorder driving the desire to escape the reality of their lives and obsessively and compulsively to abuse opiates. They have thrown us, chronic pain patients, in the ditch and ignored us like we were just more road-kill.

  9. John S at 2:18 pm

    https://apple.news/AtgWTrufnRyKrG3tZqAZYvw

    Another report out today.

    This News report explains how the “Opiate Epidemic ” started and that the in increase in Heroin use & deaths was not a surprise and maybe even expected. Soooooo the Govt anticipated increased deaths from their legislation? I just don’t like the thought of that

    Have more die now and hope it saves lives later on – that’s pretty sick and CRIMINAL if it’s true. “Just say No” didn’t work maybe selective – death by forced medication denial can be a better solution. Do we get a NUMBER or is it Pot Luck ?

    Thanks,

    John S

  10. Tim Mason at 7:14 pm

    If God walked around in public today the DEA would arrest him on drug charges for creating several plants used to help people.
    He would probably get three life sentences’ for creating the Poppy Plant, the Marijuana plant. They might even charge him with peyote manufacturing.

  11. John Sandherr at 2:45 pm

    http://phase3dd.com/tag/nktr/

    According to the follow up to the study done – posted on the attached site above

    Oxycodone takes 11 minutes to reach maximum concentration in blood plasma.

    NKTR 181 takes 2.9 Hours or 174 minutes to reach the maximum concentration in blood plasma

    For a patient in severe acute pain, 3 hours can seem like a lifetime and might make the pain worse as you wait for the medication to do its job.

    If it does work as well as Oxycodone and their is no other option for Chronic Pain Patients, I can think of much worse options to be forced on us.

  12. Tim Mason at 9:07 am

    Joy, one must be careful when using “natural products” or formulas made from natural products. In particular, plant base materials. Using green tea capsules as an example, most of the green tea comes from China. China still uses Arsenic as an insecticide on it’s tea. My brother recently had to have his blood chelated to remove the buildup of arsenic.
    Many plants remove heavy metals from the ground and incorporate them into their various parts. In particular lead is found almost everywhere at some level.
    Your best labs for heavy metal testing are found in California.

  13. John S at 8:36 pm

    ”Just remember, these people read all the misinformation found on Yahoo and TV talk shows.
    TELL NO ONE.”

    I had mentioned earlier in this post about the dose of medication I was taking, if pain patients that need Opiate medication are not willing to be honest about what helps our pain then we have lost the battle to keep it. People need to be informed, they need to hear the truth not lies. How can I write a book about Pain Management or advocate the use of Opiates for Chronic Pain if I’m afraid to even talk truthfully about it ? However, I do not go around bragging about what or how much medication I take to every Tom, Dick or Hank I run into. Remember, with all the new systems in place that track the purchase of all Controlled or Scheduled Drugs make it very easy for our medical and Rx history to get into the wrong hands – there are – No More secretes.

    Carl Hart PhD, has studied drug addiction for over 20 years and his studies show that America is in trouble with Drugs mainly because of the lies told to us by the government and other agencies. Dr. Hart believes that until we learn to be honest about drugs and drug use the problems will only get worse. Dr. Hart also believes that the problem is not the drugs its more – what is the reason people desire to use these drugs and the lack of education. The government believes talking about drugs means promoting drug use and that’s just not true.

    Now, from what I have learned about ” NKTR-181 ” it might very well be the next generation of Pain Medication but for all the wrong reasons. There will be only one way to find out if this new type of Opiate truly works and works with fewer side effects – that’s with long term use on patients with real Severe Chronic Pain. If the study I read is correct and I see no reason why it wouldn’t be then I see it as the one big drawback. The graph that was posted along with the Trial showed that ” NKTR-181 ” can take up to 180 minutes to work and start reducing the pain vs only 15 to 30 minutes for Oxycodone. Does anyone suffering with severe pain want to wait 2.5 hours for a pill to work ? Can we afford to wait when that PAIN is so bad we begin to question our very near future.

    Side effects for the new drug are very much the same as with other Opiates according to the trial or study. The big plus for NKTR-181 – Rats chose sugar water after 25 gulps of NKTR-181 – not sure if the rats were in pain !

    Thanks,

    John S

    I would be happy to try this new medication and if it works and does the job I would only worry about the long term use. Its the 2.5 hours of waiting for pain relief or – full effect – that leaves me wondering if there was no ” OPIATE EPIDEMIC ” would this new drug even be considered. I think not !

  14. Joy at 12:37 pm

    My life and health have become a continuous nightmare, with greatly increased disability, terror, rage, and hopelessness; a steady progression that began with the “Healthcare” Reform Act, and my first medication “shortage,”which has resulted in serious damage from countless inauthentic and misrepresented medications. I have co-occurring diagnoses of both ADHD and Chronic Pain.

    This article caught my attention because I recently discovered that all of the “counterfeits” with the same name as my 12 year generic stimulant, had a MOLECULE taken from the original formula, as well as 3 heavy metals put in it’s place. I have tried 6 versions of Oxycodone; one almost gave me an Aneurism. There are the same side-effects; I recommend getting a heavy metal test from a lab you can trust.

  15. Tim Mason at 3:44 am

    IBA, Those that have made it to the Methadone clinics have in some way or another been confirmed a drug addict. Most of them admit that they are addicts. I have a niece and nephew that admitted to being addicts. They stole other peoples pain medication and abused the prescriptions they stole. The levels of methadone are monitored in these clinics and levels that indicate abuse determines if they get more or not.
    Methadone is a $400/month habit and not covered by insurance. It is really sad but these kids do not have the funds to support methadone treatment.
    I took my niece to a visit and waited out side for her to complete her visit. I observed those that came and went and they were obviously at or below the poverty level and the age of the patients looked to be from 21 to 30 years old.
    The is the age group that falls into the addiction class of people. (I have an article coming up on this topic).
    My nephew told me that methadone treatment was a “living hell”. My brother paid for his treatment until he got a job. Once he had to pay for the treatment from his own check he concluded that the treatment was not worth it.
    The big reason these Addiction Centers want all pain patients to be classified as addicts is so they can get in on the Insurance Claim status of what they do. This guarantees payment and makes it a thriving business.
    All methadone treatments are located in low traffic area of town and the entrance usually faces away from the roadway.
    Methadone is the German equivalent of morphine.
    In Spain, where drugs have been decriminalized, vehicles resembling “break trucks” distribute daily doses of Methadone to users.
    This type of treatment is not for chronic pain patients, however, there are those that lobby for this treatment for US and the only reason is the guaranteed revenue drug treatment centers can make if they enter the insurance covered arena.

  16. Kathryn Masters at 12:55 pm

    I do not give much validity to any article that talks more about drug addicts problems then the real & serious problems pain sufferers are dealing…have been dealing & should not be dealng with. Those that talk more about resolving drug addict problems I don’t have any real interest in the product(s). Generally that means “placebo”….no real pain relief so will suffer greatly while the Dr(s) see that the new “molecules” have caused more suffering instead of easing it. The greatest “drug abusers” is the medical profession so how will this issue be solved? Only once in my entire life did one person from society steal my medicines…but I can tell you over a dozen health professionals including pharmacist who have stolen medicines from me. I’m like the rest of the “True Pain Sufferers”…I never got a high from my pain medicine. But I certainly got relief & right on my feet able to accomplish all kinds of necessities, even some luxuries like visiting places, friends, being involved in my community, etc, etc. And this medicine that makes me so active & successful is the very medicine you are taking away & that is constantly being refused to me. So another molecule on the block doesn’t get me excited in the least…I didn’t see what I should be seeing so I hold no true hope for this any more than I have hope you all will hear us & stop acting like your excuses about drug addicts is any justification to in reality suffer us more. I know I sound a bit crast…plz be understanding I Am fighting to speak thru the tremendous pain I’m in so I won’t be sounding like I’m comfortable ‘n have all the time in the world to be patient, relaxed & talk at great lengths of being civilized about things. Especially when its all quite barbaric to me.

  17. Ive Ben Aiken at 10:17 am

    Worrisome the way that the “authorities” will fast track a new medication for pain because it may be less likely to be abused because it does not give the patient a feeling of euphoria, a high. I, unfortunately have had to take pain medication for 23 years. I did not plan to do so.

    The surgeries I had for lower back pain actually did do what they were supposed to do. Unfortunately they were very invasive to my body and have caused non stop uncontrolled pain. WHATEVER you call lower back surgery, a failed surgery or the very rare surgery with little pain after healing, there is uncontrollable pain with OTC medication. As I said, I have been a chronic pain patient for a long time. I used the medication to be able to continue to support my children, my wife, and myself. I have stayed active with exception of the process of healing from two disc surgeries. The latter being the most invasive because of surgical metal and screws being placed in the lower back vertebra for support of the spine. It has been painful from the start and it has NEVER stopped.

    I own and have ran a small building company since I was 28 years old. I had the motivation to ” stay on my feet” and work. I have been in two different “pain clinics” with the current doctor being absolutely professional with prescribing opioid medication. I concur with the reasoning of the CDC getting OUT of controlled opioid prescribing. Let the physicians do what they were educated and received a license to do! Everyone is different with chronic pain. Metabolism, weight, and even their motivation to do what is needed to survive.

    I have been STABLE on opioid medication for at least 19 years after going through the process of trying different medications at the beginning of the realization of having chronic pain for the rest of my life. I have not experienced a “high” with opioid medication for about 18 years. Methadone is being unfairly discriminated against with the CDC “morphine” equivalent of 90 milligrams of an opioid medication per 24 hours adopted by the state I live in. Reduced from 100 milligrams to 20 milligrams per day in less than 2 months. I am advised by my physician to change medications and try to find an opioid medication that he can “legally” prescribe in a sufficient dosage for me without endangering his professional licensure from the CDC. I am starting all over again!

    The only legal choice I have to control pain is to “try” other opioid medications that can be prescribed at a sufficient daily dosage because I DO NOT desire any effect from medication other than sufficient pain control so I may keep working. I am already having days that I just can’t defeat the pain and must stay inactive. It will cost me my livelyhood unless the CDC and government leaves the prescribing medication and control of dosage to a personal physician!

    Kratom, CBD oil, I have spent a good deal of money for these “medications” that are not very efficient but do help slightly. Worse thing about these two “meds”, is the lack of any type of quality control. I understand that one or the other or BOTH do in fact help a great deal of people but, again I am a leery of what I am actually putting into my body that is being advertised as safe and “quality controlled”. Marijuana use is not legal in my state and I don’t believe I would like the high associated with it. Again if it works for you, and it is legal to use, smoke it, eat it, or drink it!. I would probably smoke away if the “guideline” stays ENFORCED! Constant, severe pain is a POWERFUL condition to reckon with. I pray that the CDC will actually LISTEN to the people who are suffering and relax the “guideline” so we may live with some amount of quality of life and for many just be able to function.

  18. Angel at 9:17 am

    Pain patients being effectively treated with opioids would dispute the necessity of this medication. The premise that opioids are a problem that must be solved is simply not true. They’ve effectively treated pain for over 1,000 years. Only the last 10 of those years have we seen significant shifts in attitude towards these drugs due to addicts obtaining and misusing these drugs. We need to go back to rational thought and discussion on opioids and get the propaganda and lies out of public debate on this issue.

  19. Jean Price at 3:46 pm

    Okay, the down side:
    The premise that WE are the problem…and that’s WHY we NEED these NEW medicines (which, like the other anti-abuse ones, will sadly translate to more expensive, and less proven for the vast majority of patients with ALL types of pain, and definitely will NOT be time-tested!!)….well, it’s ALL just pure hog wash! Isn’t this placing all the burden of BLAME for addiction to opioids on US….and on the OPIOIDS THEMSELVES…you know, ALL the LEGAL ones ALREADY available for use MEDICALLY FOR PAIN! (The ones which have been working well…for ages! Which are now being denied and reduced to non-therapeutic levels!!!).

    So what this kind of research SAYS to me is…law abiding, compliant patients IN PAIN….who take these medications….under the EVER WATCHFUL EYES and careful followup of our physicians…solely for the purpose of decreasing physical pain enough to function a little better and to have some semblance of a life…are now being USED as an EXCUSE to make MORE money for pharmaceutical companies! Because that’s another way of saying all of this, isn’t it?! NEW medications with addicts in mind, and oh yes…they may help pain too!! Dumb!

    You know, WE don’t actually need new, fast tracked drugs or anti abuse drugs…for PAIN….like ones which have only been tested for back pain…and only with a very small number of patients…without any long term effects known of using these new “molecules”!!! ThIs is a recipe for disaster, in my mind! What we need is really simple…we need appropriate care for pain RETURNED to the hands of our doctors, for patients to ALL be treated with respect and not judged guilty when they are innocent, and we need lots of research about PAIN…and ALL the MANY MODALITIES of treatment…not just medications!! We need better health care coverage of ALL MODALITIES, including platelet and stem cell therapies, massage, acupuncture, yoga, herbal remedies…with marijuana not being made cost prohibitive…and alternative medical care visits and treatments, and patient support in the form of grief classes and homemaker and transportation services!! To include OUR MILITARY AND VETERANS TOO!

    YET FIRST we need the CDC guidelines TRASHED…and the CDC must be banished COMPLETELY FROM ALL PAIN CARE…where they never belonged in the first place! AND we need the DEA to return to policing ILLEGAL DRUGS FLOWING INTO OUR COUNTRY…and leave our physicians to care for their patients!! (As for a few doctors who might innocently over-prescribe, or the even fewer doctors who might decide to make money by illegally supplying drugs…plus the few NON PAIN people who are already addicted…who might try to find a “legal” source of drugs with a physician to feed their addiction…ALL of these can be stopped relatively easy…WITHOUT all the across-the-board gestapo tactics we see now!!)

    So in effect, what we REALLY need is a RETURN TO SANITY REGARDING PAIN CARE….separating ONCE AND FOR ALL pain care from addiction…since they are two very DIFFERENT ISSUES! With two very different patient profiles and needs!! And we can return to using the medications we have now, and have had for centuries…the ones well known to lessen pain…and they do, and thereby improve the lives and functioning for those with life-limiting pain! And of course, we need to keep ADEQUATELY FUNDING research…of PAIN and understanding it better! Not just Looking for new medications…yet also researching new treatments, without taking short cuts that could possibly jeopardize patients!

    Now the up side:
    This new medicine “sounds” very promising! So…IF this new medication was covered by insurance, and IF it’s not outrageously expensive, plus IF it works JUST AS WELL and WITH NO FURTHER SIDE EFFECTS, SHORT TERM OR LONG TERM…(hmmm, all BIG “IFS”)…well, it would be great! Wonderful!

    And it would be really good IF this actually meant we could be treated FOR PAIN AGAIN, and treated with ENOUGH helpful medication…without all the endless current hassles! WOW, to actually return to functioning BETTER—and with A LOT LESS suffering! Yes!! This would be just fine with me…as long as IT’S PROVEN EFFECTIVE for all the types of pain I have! And as long as IT’S PROVEN to have NO FUTHER SIDE EFFECTS…OVER TIME! (Like for a fairly LONG time…similar to those we ALREADY HAVE, which ARE very appropriate for pain…IF they were STILL BEING ALLOWED! Which they would be…IF things hadn’t changed so drastically…and the CDC had stuck to JUST communicable disease control and had NOT meddled where they don’t belong!).

    So, count me in THEN!! I’d at least try it THEN! Before then, well I’m just not so sure! I’m NOT big on taking unnecessary risks! For now, I’m just hoping AND praying this isn’t FORCED on us, like all the OTHER anti-abuse medications have been, along with ALL the other CHANGES in pain care that also have occurred! So much for “land of the free”…right?!? Sometimes I really wish our government knew what this is supposed to mean, and they ALL would act accordingly!!!!

  20. Tim Mason at 7:47 am

    One important thing here is to keep your medications a secrete. Especially from fellow employees. Not only is there a jealousy factor, they can use the information to get you fired.
    If you happen to use an FMLA day they are going to assume you were to high to come in or were extending last nights party.
    Just remember, these people read all the misinformation found on Yahoo and TV talk shows.
    TELL NO ONE.

  21. Tim Mason at 6:58 pm

    Odd that they did not mention the incidence of “headache” in the list of adverse symptoms.
    Nucynta works similar but causes severe headache in about 3% of the population that takes it.

  22. Michael G Langley, MD at 6:49 pm

    Waneta1,
    One must consider that this is an opiate molecule. The difference between it and morphine is minimal. The advantage is reportedly that it does not cause the high and desire for abuse. Other than that, the great majority of all of us pain patients would do well with the old molecules, if they were prescribed and taken correctly. Most pain patients do not abuse their drugs. The cost of this new med is the thing that worries me. It makes them drug dealers in another form. They know the can charge what they want when we have no other choice of medication. It is like having a monopoly on our pain relief! It makes no sense to take opiates away from, the vast majority of,, the pain patients that don’t abuse their meds. But, we have politicians and the government in charge! They are so ignorant that they will never be able to make an intelligent decision!

  23. Sonya at 4:27 pm

    I agree with the others. Those of us with chronic pain don’t get this high they are talking about. Our bodies are using every bit of what we put in to help do it’s job and relieve pain. And I’m sure not going to trust a fast tracked drug that years later they realize it causes major organ damage or other problems. Great for them wanting to find a new medication but do it the right way! Would they fast track meds for cancer or diabetes? Why should chronic pain sufferers be treated any differently? No way am I trusting something new and untested for its intended use over a medication I know is working and not causing any damage.

  24. John S at 2:29 pm

    It saddens me to read that what is a big positive for this new drug is the absence of
    ” Drug likeability ” or ” hey I’m not getting high from this stuff”,

    If I wasn’t getting high from the 400 mg of Oxycofone I was taking 6 months ago I doubt that it’s a HIGH I’m looking for.

    Back in 2011 my PM Dr had me on Actiq 1200 mcg up to 4 x a day for breakthrough pain. I was working 56 hours a week and walking up to 4 miles a day working in Sales at a local car dealership. The other salesman would see me struggling just to walk and then the Drop foot would set in. When the pain reached a level that would send me home I would use the Actiq and keep working. Later I asked to be weaned off the SUCKER after one of the young guys said / hey John, isn’t that a Fentanyl Lollypop ? Never did I get a HIGH from the Actiq, what I did get was near instant pain relief. My pain level would drop from an 8 to a 6 in just a few minutes.

    I think what they should be doing is to find a way to make all Opiate Schedule 2 & 3 drugs tamper proof. Find a way to keep people from using it to Snort or Inject and any other method that will cause harm.

    It also seems like the article has blamed Chronic Pain Patients for the abuse and transfer of Opiate pain meds.

    If they don’t get the real problem right / it’s going to be harder to get a real solution.

    Scares me to think what kind of side effects a new drug like this will have after using it for 18 months. I’m sure it’s on the fast track for who knows what.

    Thanks

    John S

  25. Veronica at 2:09 pm

    I don’t need a ‘new’ opiate. I need a doctor who isn’t afraid, or forbidden, to write me the script to begin with!!

  26. Kim at 7:16 am

    Sounds promising . But, one key thing is missong… Over and over i have read ( and experienced) that people who are really in pain .. true, acute chronic wicked pain, do not get high from their meds… at best they get some pain relief. This story about a new wonder srug doe a not seem to address that point… and it does, sadly, talk about the “”opoid epidemic” and pain patients as if there is a syrong tie. Sigh… On the upside, maybe newer better pain control is coming? Odd though that there we not other side effects listed… wonder what else is in the “new molecule”…

  27. Cynthia at 6:52 am

    This study should have used chronic pain patients that are using opioids to get a true standard of results. Not a true comparison for the two different drugs!! Chronic pain patients taking opioids don’t get a high just relief

  28. jess at 5:22 am

    How stupid, why do this when the fda,cdc,cms,va,dea and all ins. co. prohibit perscribing opioids for CHRONIC PAIN? And no doctors will even treat pain patients anymore and definatly will not perscribe opioids for chronic if they want to keep their medical license, practice,and freedom. Whats the point.

  29. Wanita1 at 5:03 am

    So 10 million people in the USA suffer from chronic pain, 15000 died last year by taking NSAIDS . 27.000 people in the USA who were mostly NOT chronic pain patients died because of over dose from taking drugs made and sold on the streets.

    The lives of Chronic Pain Patients mean little? We are supposed to be the Guinea pigs? Fast tracking this drug is unsafe to do, 10 million people’s lives are at stake.in comparison to the 27,000 who were not even mainly pain sufferers. I don’t trust it. A new molecule? Remember what happened to pregnant mothers when they took Thalidomide? Does this new molecule cause liver damage or kidney damage? If 25 years has gone by then maybe they know but I doubt it.

    Opiates are found to be safe when used appropriately. No kidney damage, no liver damage. We are supposed to trust our health to a NEW MOLECULE? How long were they tested in the lab? How many years? The standard medications have been used for hundreds of years and are known not to fry organs.

    This drug needs to be tested and studied for an adequate period of time and not fast tracked because of ignorance.