FDA Approves Potent Hydrocodone Painkiller

FDA Approves Potent Hydrocodone Painkiller

A day after saying it wanted to restrict access to hydrocodone, the Food and Drug Administration has approved a new more powerful version of the opioid painkiller that some critics say is dangerous.

Zogenix-ZohydroZohydro, which was developed by San Diego based Zogenix Inc. (NASDAQ: ZGNX), will be the first pure hydrocodone painkiller sold in the U.S. Combination versions of hydrocodone, such as Vicodin, typically contain acetaminophen and require dosing every 4 to 6 hours. Extended release Zohydro could be taken just twice a day for chronic pain.

“Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids,” the FDA said in a statement.

Zohydro will be classified as a Schedule II drug, which means it can only be dispensed through a physician’s written prescription and no refills will be allowed. There are also more stringent recordkeeping, reporting, and security requirements for Schedule II drugs.

On Thursday, the FDA said it wanted to reclassify all hydrocodone products as Schedule II drugs because of their risk of abuse.

Zohydro ER will carry new updated labeling and stronger warnings that the FDA is requiring for all opioid pain medicines. The agency is also requiring post marketing studies of Zohydro to assess the risk for misuse, abuse, and overdose after long term use beyond 12 weeks.

However, the FDA is not requiring that Zohydro be made with a tamper resistant formula that would discourage addicts from snorting or injecting the drug.

Late last year a panel of pain experts advised the FDA to reject Zohydro because of potential abuse of the painkiller. The vote was 11-2 with one abstention.

“If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” FDA staff reviewers wrote in a report to the committee.

The agency is not required to follow the recommendations of its advisory committees.

“Just as the FDA was making some steps forward in the fight to end prescription drug abuse, they take major steps back with the approval of Zohydro ER, which will now be the strongest prescription painkiller available,” said Rep. Bill Keating of Massachusetts, a longtime critic of the FDA, who is sponsoring a bill to require all brand name painkillers to have abuse-deterrent formulation.

“FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features. This is outrageous. Abuse-deterrent technologies should not be the anomaly – they must be the norm.  The technology is available and the FDA should be requiring pharmaceutical companies to employ it.”

Zogenix maintains that Zohydro would actually be safer formulation of hydrocodone because it does not contain acetaminophen, which is a leading cause of acute liver failure in the United States. Nearly two out of every three acetaminophen overdoses are attributed to hydrocodone-acetaminophen products.

“Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids,” said Dr. Srinivas Nalamachu, MD, a pain specialist and investigator in clinical trials of Zohydro ER.

“A significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients.”

Zogenix said it has begun developing an abuse deterrent formulation of Zohydro ER and that it was “committed to advancing the program as rapidly as possible.”

Authored by: Pat Anson, Editor

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concerned

Wow, I have seen 5 people die when they made oxycontin and opana crush resistant. They still found a way to break them down and started injecting them. They had a bad addiction, but I wish they were still here snorting them than not here.

Marla Renee Wilson

I think this is good news. Doctors just need the freedom to prescribe this to legitimate pain patients without fear. Drug addicts are not going away and neither are pain patients. I would be willing to try this new medication. Addiction has become such a dirty word when there are many complications caused by drug abuse that are just as dangerous. At least with addiction we know what we are dealing with and how to treat it. I choose addiction over kidney failure anyday. At my wits end with chronic pain treatment, I don’t fear addiction. I’ve been effectively weaned off many medications and eventually put on other medications. It’s my choice. We need to take fear out of the equation. If my quality of life improves because of a medication that’s great news to me. Suffering does not belong in this medically advanced society. Weeding out drug abusers/dealers is up to the police. I’m not telling doctors to just prescribe to anyone but we need to let them practice their chosen profession without fear. So many people suffer because of it. I don’t think that’s the purpose of advancement in medicine.

Christina

Reality is if people want to abuse something your not gonna stop them. They will find something else or another way. It only effects the people who need them and can’t get them. What they need to be focusing on are better ways to make pain management more effective. Not allowing private pharmacy to sell medications for cash only. This problem is making more issues then anyone cares to look into. The states are getting more legal money out patients who are in this situation and it is WRONG. It needs to stop and the government is aware of it because they have created shortages of medications.

Janice Reynolds RN, BC, OCN, CHPN

The advent of this medication is a good thing-not having an abuse deterrent formula is not. That being said, the really unfortunate thing is the announcement of this medication gives a forum to the “anti-opioids”, “war against addiction is the most important thing, too bad people with pain are causalities, and the “I know how to treat chronic pain” promoters most of which preach inaccurate information based on opinion.
There are more people with persistent pain than with heart disease and diabetes (IOM’s 2011 report). Most people with pain are not addicts (and by the way, even those who are addicts deserve to have their pain managed. Back pain is NOT the only type of persistent pain and even within the area of back pain there are different types and different patient responses to treatment. When used as a medication the term is opioids (not opiates) and heroin is not included in that group. Millions of people use stable doses of opioids to treat their persistent pain. Yes pain should be treated holistically but it is difficult for many people with pain to even find a provider who will take them as a patient let alone someone who is competent (pain is still not covered well in school especially persistent pain and most providers-physicians and nurses- continue to be educated by the media or poorly done studies, i.e. the CDC). Medication is not a “bad” thing for many types of pain. Medication is not necessarily opioids; there are other medications which can sometimes work better than opioids for a particular person or pain syndrome or they may be used with opioids to lower the dose needed of the opioid. It is correct insufficient attention is paid to the dangers of NSAIDs but I would say too much has been said about acetaminophen (which is basically a problem when over dosed or used with alcohol). Medications of all sorts are person specific (oxycodone works well for me, hydrocodone just makes me sick). Non-pharmaceutical interventions such as acupuncture, massage, chiropractic therapy, etc. can be very helpful for some problems (and have some evidence base) yet they are not paid for or inadequately paid for by most insurances and without insurance unaffordable. Pain should be treated as we say in palliative care physically, psychologically, socially, and spiritually yet this approach is all too seldom used.

Melissa stallings

Terri Robbins have you spoke with your doctor about a different t pain medicine. I have a very bad back, had one back surgery, I have a reherniated disc on L5 and this happened in the recovery room to remove the first herniated disc. The surgeon was suppose to fuse it but chose not too so when I woke up, I was in excruciating pain. Worse than before surgery. They refuse to do any more surgeries due to all the scar tissue. I have spinal stenosis, degenerative disc disease, bulging discs throughout the spine and a herniated disc in my neck at the C4 level. I took hydrocodone for many years and my body got so use to it that I was in the highest dose and taking 2 pills every 2 hours just to be able to walk. I could not stand or walk for more than 15 minutes or sit for more than half an hour. I cannot sleep on my sides anymore. I actually sit up to sleep. So I went to a new doctor because I was afraid the next medicine I went to, it would do the same. Well my new doctor (I’ve been with her 3 years now) has been awesome. She believed me when I told her I can’t take hydrocodone anymore and the reason why. So she spoke with me about a pill called methadone. I started at 90mg every day. I took 30mg every 8 hours. I did this for the first 2 1/2 years. Now I have been able to ween myself down to 30 mg a day. I take 30 mg at night when I try to lay down. I will tolerate some pain so my body doesn’t get tolerant of it. I am still able to so many things and even walk further with the 30 mg a day as I did with the 90mg a day. I would really try this medicine out. It is used for chronic pain as well as other things. But or you I think this would be the best option to get you up and mobile more. There’s nothing worse than being stuck at home because of all the pain it causes.

Terri Robbins

As a long time cronic pain patient with 3 failed back surgeries I need something to help me live a normal life. Ihave a fushion from shoulder blades to my rear-end and I cant stand longer than a few mins with out hurting so bad, my legs start shaking so life as I knew it BEFORE surgery isnt there anymore. I also have Hep c from 1st surgery…. so the vicoden w/tylenol I have to watch. I need something to help me live out the rest of this life with some digity and less pain..I am 65 and not a druggie I just want to be able to wash dishes….. stand for an hr..anything without feeling this much pain .. Has to be something that can help.. A Dr who would helpIpray for help..

In the world of medicine when a new drug is introduced that is actually a “clone” of an old tried and true medication, we call them a “me too” medication. The business of medicine is trying to grab market share for profits … which is what the business community does very well. The FDA should not be in that “business” of allowing this to happen especially when there is already an epidemic of pain and misery that is going under acknowledged and under treated. A “me-too” medication will add more fuel to this chaotic, unfair, unethical community that needs a different option. The medical community already have some pretty potent pain relievers in the opiate family, a drug with morphine-like effects, derived from the opium poppy plant; Codeine, Buprenorphine (Suboxone), Methadone (Dolophine), Morphine (Avinza, Duramorph), Opioid, eg Heroin. What we don’t have and seriously need is a healthcare community that will address acute and chronic pain in a more holistic, natural, innate, God given way. This is the way humans have dealt with these issues from the beginning. You have to get at the core issues of what actually starts and fuels all chronic (non-infection/cancer) pain problems. This core issue was uncovered in the 50s and 60s by a few orthopedics physician, therapist and healers went they began having to treat patient who failed replacement surgeries. Their deduction was “let’s begin this therapy before replacement surgery to relieve pain and dysfunction … and it worked very well. The went on a crusade to change the furgery protocols but met with a lot of resistance that is still resisting today. Which is why we have the “me-too” pain medication proliferation. This core pain cause is like an invisible cancer, not seen under the microscope, in blood test, on any scan, MRI or sophisticated study. Although a lot of doctors will suggest that is what it might be as per blood test or what is seen on a scan or MRI it is not completely true. These doctors will suggest a “fix” that will help or work but not completely. Then since it is not complete and true the fix will falter and both the patient and the provider are left wondering and at odds with the results. The next incomplete treatment are pain pills of all types and combinations, none of which will invite healing and leave the patient dependant on pills. This core pain issue will thrive in this environment and root deeper into the flesh and expand widely into other areas of the body … further confusing and frustrating. Myofascial pain and dysfunction is the cause and is the great masquerader of just about any medical conundrum. Here is how to treat this devil; >The first level of care, treatment or therapy is with the application of external energy, stretching and movement; heat in the form of infrared, cold laser or a pad; massage, yoga, pilates, cupping, twisting, unwinding, TENs units, Electrical Stims, Spray and stretch, hands-on manipulation. These… Read more »

Steve

I don’t understand why everyone companies about opioids abuse when more people die from NSAIDs or acetaminophen than opioids.

Also, addicts can still abuse abuse-deterrent formulations. Unfortunately, these systems are tested in healthy volunteers after administering naloxone. The actual chronically ill patients typically find that the abuse-deterrent formulations are significantly less effective. Personally, the new Opana ER and new OxyContin have no effect, however oxymorphone ER (non abuse-deterrent) and oxymorphone IR are fine.

Oliver Twist

Oh great! More dope for the masses! Keep them numb and dumb!

Deanna

This is a step FORWARD, not backward! Adults in chronic pain desperately need to have different variations of opiate pain medications available to them, as we build tolerance to one, we can switch to another. We are ADULTS, in chronic pain! We have the right to use pain medications! There will ALWAYS be drug abusers! Its pathetic that drug abusers are able to get high doses of methadone for their addiction problems, but chronic pain patients have to suffer because drs. are too afraid to prescribe! No one in chronic pain should ever have to suffer!!! Yes, I lost a child to drug addiction, so I do know the “other side” to this, but i’m also a chronic pain sufferer, struggling to find a dr. to relieve me of debilitating pain!!!

GeordieKin

It’s good news that company’s are still moving forward in developing new or at least different variations of pain relief medications for patients. I only wish there were more physicians for those with chronic debilitating pain to turn to as the drug abusers have those suffering and those willing to help in a stronghold.