FDA Commissioner: Zohydro Won’t Increase Drug Abuse

FDA Commissioner: Zohydro Won’t Increase Drug Abuse

A controversial new painkiller is no more powerful or addictive than other opioid medications already on the market and pain patients should have access to it, according to the head of the Food and Drug Administration.

FDA Commissioner Margaret Hamburg

FDA Commissioner Margaret Hamburg

“Despite claims to the contrary, the fact is that the top dose of Zohydro is no more potent than the highest strengths of other extended-release opioids like Oxycontin and extended-release morphine,” said FDA Commissioner Margaret Hamburg in a blog on the FDA website.

A wave of controversy has surrounded Zohydro – the first single ingredient hydrocodone painkiller sold in the U.S. — since its introduction in March. Some addiction treatment experts have claimed the new painkiller – which does not come in an abuse deterrent formula — will fuel a new wave of narcotic addiction and overdoses.

Last month Massachusetts Gov. Deval Patrick tried to ban the prescribing and dispensing of Zohydro in his state, a move that was blocked by a federal judge who ruled the governor was interfering with the authority of the FDA to regulate prescription drugs.

The agency approved Zohydro last year over the objections of its own staff and advisory committee, which warned the painkiller could be abused even more than currently available hydrocodone products.

“The approval of Zohydro is not likely to significantly change overall opioid prescribing and use by patients suffering from pain,” said Hamburg.  “Rather, the most likely patients for this medication are those who are currently taking an immediate release hydrocodone product chronically, or people taking another extended-release/long-acting opioid. And this drug is unlikely to increase the number of people abusing opioids.”

“We have heard from many people who must cope with often severe pain on a daily basis. These are people who need a variety of therapies to have any hope for a quality life.”

After the judge ruled his emergency order was unconstitutional, Gov. Patrick announced new restrictions on Zohydro that require doctors to evaluate a patient’s substance abuse history, provide a letter of medical necessity to pharmacies, and sign a pain management treatment agreement with patients who are prescribed the drug. In addition, physicians must also use the state’s online prescription drug monitoring program, which tracks the prescriptions of controlled substances such as Zohydro.

Zogenix (NASDAQ:ZGNX), Zohydro’s San Diego-based drug maker, filed a federal lawsuit against Massachusetts this week saying the new regulations are unconstitutional and impose “draconian” restrictions that “amount to an effective ban of the drug”.

While saying the restrictions “are precisely what responsible physicians should be doing,” Hamburg said it was unfair to single out Zohydro.

“We can’t just focus on one drug, Zohydro, alone. These requirements would not apply to the prescribing of any of the other opioids on the market that account for some 250 million prescriptions and 18 billion tablets each year. Unfortunately, to date considerable misinformation appears to be diverting attention from more comprehensive policy solutions that apply to all opioids,” Hamburg said.

The FDA Commissioner said regulations should address “the real root causes of the problem,” which are excessive prescribing of opioid pain medications, improper disposal of unused drugs, and inadequate physician and patient education.

“Addressing the opioid crisis by focusing on a single opioid drug will simply not be effective,” said Hamburg. “At the end of the day, the complex public health challenge of opioid abuse requires a comprehensive and science-based approach involving federal and state governments, public health experts, opioid prescribers, addiction experts, patient groups and industry. Then, and only then, will we truly solve this problem and protect the public health.”

Authored by: Pat Anson, Editor

There are 14 comments for this article
  1. Jammie at 4:23 pm

    Another issue pain patients are facing is pharmacies forcing them to have 3 or 4 non pain prescriptions filled for each pain medication. These are the independent pharmacies. This has become common practice and I haven’t come across any that don’t require this. Insurance companies are paying for this. Or, for those on Medicaid, the government is being milked for A LOT of $$ in unnecessary prescriptions.

  2. Ronnie at 12:50 pm

    Hey Michael (Comment #2)

    I also live in Louisiana but on the north shore in Madisonville. Is there any way for us to communicate personal? I don’t know of any doctors prescribing Zohydro and personally me and my PM doctor are on a great plan where I’m not in much pain where I’m unable to do things, like get out of bed, or go to sleep, and do regular daily life actives. I know my limits, I am on EXALGO ER 16MG along with medicine for breakthrough pain. Maybe you should try that. I personally didn’t know what to do or ask… I let my PM/Neurologist talk to me and I answered questions and asked questions and started off with the prescription he gave me first which causes me go to into the ER with a Grand Mal Seizer. That’s when he placed me on EXALGO ER 16MG. It’s very expensive and I like the Extended release.

  3. Michael Solomon at 11:17 am

    Need to know my pain management rights, and is there a dr. In the metairie la. Area that is prescribing zohydro to disabled patients

  4. Carlos at 11:44 am

    If you want pain relief going to the VA is just another nightmare. I’m a combat wounded veteran with thirty plus years of severe pain, and have seen this agency bounce back and forth when it comes to pain relief. Keep in mind I’ve had surgery, injections, and all kinds of medications that have lots of side effects but don’t relieve pain. This agency oscillates back and forth. Some 5-8 years ago there were posters everywhere in the hospital claiming YOU HAVE THE RIGHT NOT TO BE IN PAIN. So what happened to that? Last year, when I asked to be switched from morphine, which was really adding to my depression, I was switched to Fentanyl. Under the new VA rules , you aren’t given an equivalent amount but, after waiting a week for permission from the pharmacy to use it, started with the smallest possible dose, required to wait two weeks to tell the doctor, then get pharmacy approval for the next higher dose, than wait two weeks more, etc., until the highest dose is reached. In the meantime, suffer! Now, after years more of voodoo medications that just make you disoriented and lose your balance, I’m referred from the pain clinic to the Interdisciplinary Pain Clinic, which, without seeing me, has already decided that I’m receiving too much pain medication! This, I presume, is the clinic that uses hypnosis, Mindfulness Meditation (which is all the rage here), external TENS units, and EXERCISE! As if they haven’t been handing us the sciatica exercise sheets for thirty years. I has very successful (civilian) cervical surgery 14 years ago, which worked for 13 years until I was rear-ended in a car accident and ruptured the next disc up, leaving me with crushing pain in the hands, wrists and arms, in addition to fully enveloped lower back pain, hip pain, and severe burning in the entire right thigh. And, now, having been treated for PTSD and depression since 1995, I am scheduled to have meds reduced and be treated with New Age wonders instead of attempting surgery or being referred to a civilian clinic that can treat some of these issues. And everyone wonders why you have this epidemic of pills flooding the streets? They wouldn’t be there if no one was buying them! (PS It;s probably evident that that I’ve been increasingly suicidal since the additional pain hit over a year ago. It’s been suggested that I try heroin first, though.)

  5. Dennis Kinch at 12:30 am

    Aren’t we talking about Hydrocodone minus the tylenol?
    Who wants to try it the other way – throw all the drugs you can find at people and let the adult in them decide what works. Just numbers and percentage-wise, this makes more sense than prohibition and puritanistic attitudes ever did. Maybe the street users will just keep overdosing solving a few problems.

  6. Pauly at 6:05 pm

    Christina, in my opinion, you are the only one who knows what she’s talking about.

  7. dave at 9:03 am

    John I think you understand that in America our thought leaders are not immune to the same excesses and deficiencies of the masses.
    Critical thinking skills and dedication to the public good in government are easily trumped by commercial interests, narcissism, resource conservation theory, and a great inability to dream boldly of a better future.
    My book on pain care will argue that due to the failings of government and thought.leaders, people in pain are excessively burdened to find what works for them.

  8. dave at 8:52 am

    Kurt in 2013, 18billion opioid pills were precribed,that is 60 pills for every American. Since you don’t believe that is enough how much more opioid do you believe are enough.
    I understand the estimates of opioid diversion vary considerably as do the estimates of the cost. In nyc an additional 200000 dollars was budgeted for drug take back programs. From my point of view my tax dollars shouldn’t pay for such. When prescribing meds doctors or pharmacies should provide a box to return unused medications
    I do not believe that opioid are effective medications for most chronic pain conditions. But let us suppose for a moment they were. Since opioid only address the sensation of pain and don’t cure the underlying condition, the
    danger is the person in pain may feel fine while the underlying condition is getting worse.Even Ahrq pointed out this problem. Dr Fishman also pointed out that even with good pain relief some people are not interested in functional restoration.
    In my experience as a counselor and such can be found in numerous books on pain,as well, doctors may provide comfort oriented medications for pain like opioid and not treat underlying pathology.
    The dangers and failings of the opioid economy are becoming more problematic. As someone who had pain for 4 years I did not consider comfort oriented care as I wanted to get better and not just feel better. And for 14 years I am better and have no pain.
    As you seem to make a point of being stimt I assume you won’t be a cognitive miser when it comes to pain care and will make the effort to be
    thoroughgoing

  9. Scruffy Fitch at 6:23 pm

    Zohydro is allegedly being prescribed in Alabama by two Physician Assistants at a level 140% higher than the rest of the country; however, the rest of the country is allegedly seeing a low number of prescriptions per representative (attributed to coupons with the exception of Southern CA). Thus, if this turns out to be true (and the company is not on a fishing expedition), how can you FDA Commissioner Hamburg justify this aberration? Moreover, I would want to know why Zohydro literature is being distributed to General Practitioners throughout the country? There are many other inconsistencies, but as our FDA commissioner you should be focused on these kinds of issues to learn if they are true.

    Moreover, knowing that Purdue was coming to market with the same product, but with an abuse deterrent, why was there such a rush to approve Zohydro sans any realistic kind of patient protection? Commissioner, am I incorrect in saying that Zohydro won approval based on a small fraction of the population that actually needs this opioid (in your opinion) to manage severe “end of life pain” (as another potential “go to” if other opioids fail)?

    Commissioner, you now have two products that can be fast tracked and approved. One of those products that is seeking approval is manufactured by a company you claim to have superior deterrence capabilities (with respect to your comments made to government). Thus, I pose the question why is Zohydro still on the market and open to anyone and everyone?

  10. John Quintner at 3:16 pm

    Dave, I too cannot see the logic in Dr Hamburg’s argument. On the one hand she expects doctors to restrict their opioid prescribing whilst on the other hand she favours the addition to their pharmacological armamentarium of yet another potentially addictive opioid that will no doubt find its way to the market place for illegal drug use. Could I be missing the whole point of her argument?

  11. Kurt at 12:41 pm

    The FDA has been harping on excessive Rx of opiates as a cause of this so-called “epidemic” for many months, yet, how accurate is that assumption?

    The DEA claims that “There are no conclusive estimates as to the total amount of illegally diverted prescription narcotics, depressants, and stimulants available in domestic drug markets.”

    Yet in last year’s National Drug Threat Assessment, the DEA claims that “prescription drugs disbursed to pharmacies, hospitals, practitioners, and teaching institutions has increased steadily over the past five years, thereby rendering more of the drug available for illegal diversion.”

    (source: http://www.justice.gov/dea/resource-center/DIR-017-13%20NDTA%20Summary%20final.pdf)

    They’re contradicting themselves — without a conclusive estimate of drugs diverted, you can’t connect an increase in opiate Rx with the increase in drugs diverted.

    Looking at the “epidemic” DAWN (Drug Awareness Network), reports that there were 180,000 (non-heroin) opiate-related treatment admissions visits to the ED in 2010.

    When hospitals or pharmacies lose track of controlled medications, they are required to report that loss by filing form DEA-106. Journalist Shawn Musgrave filed an FOI request for these statistics. The resulting Theft or Loss of Controlled Substances Report lists almost 10 million doses of controlled medications went missing in 2012.
    (See: http://www.muckrock.com/foi/united-states-of-america-10/stolen-controlled-substances-reports-6206).

    It sounds to me that FDA is ignoring a significant source of street pharmaceuticals in its desire to link drugs on the street and the fact that doctors prescribe more opiates these days. Ten million opiate doses goes a long way to helping 160,000 people find their way to the Emergency Department.

    A 2007 study examining the prescription drug abuse problem (PMID: 17305688) reported that the regulators they interviewed believed drug diversion to be a result of two major factors — doctor shopping (40%) and Rx forgery (35%), with residential burglary (6%) and pill mills (3.4%) the next two largest sources.

    With forgery providing 35% and “pill mills” providing a surprisingly small percentage (3.4%) of available street pharmaceuticals, this data contradicts the FDA Commissioner’s claim.

    The temptation of regulators to “just do something” is tremendous, however, it neither helps the so-called “epidemic” nor the chronic pain community to make these policy decisions without first understanding key facts about the source of diverted drugs.

    We must closely examine every claim regulators make about the source of the opiate overdose problem. It is very important that both pain practitioners and the chronic pain patient population do not accept arbitrary regulation of our treatment options based on political need and bureaucratic obfuscation.

  12. Steve M at 9:12 am

    Drug abuse is a minor issue compared to the lack of pain relief for intractable pain patients.

    Abuse proof intrathecal morphine pumps aren’t even available to many patients because doctors aren’t willing to deal with the DEA restrictions.

    I used to get Actiq, but thanks to REMS, they aren’t available anymore.

  13. dave at 7:34 am

    The FDA is part of the reinforcement loop of the opioids economy-as clearly evidenced by the 15% adherence rate to opioid rems, 19 members of Congress, 29 state attorney generals, and several state legislators opposed to Zohydro, the continuous escalation of failure in controlling heroin or opioid use, and the 18 billion pills of opioids given in the U.S. in 2013. Moreover, the FDA knew before approving of Zohydro that Purdue was working on an abuse deterrant form of Zohydro-and could have told Zogenix to develop an abuse deterrant form of Zohydro.
    Dr. Hamburg puts profits before people- let us see her proof of the effectiveness and safety and effectiveness of zohydro. GAO research has shown her staff lacks training in evaluating the results of research. And opioids lack long term effectivesness for pain. In fact a number of people dropped out of Zohydro studies-and i believe a few people died of Zohydro.
    Ms. Hamburg an dthe FDA have failed to serve the public good- during their time in office matters have gotten worse- their efforts to control opioids lack thoughtful planning. Should I mention that Dr. Hamburg and her husband have had very substantial financial interest in the pharmaceutical industry.
    The FDA serves commercial interests to the detriment of the public good. Dr. Hamburgs crocodile tears are no confession of failure and no energetic plan is in the works to improve the current sorry state of affairs when it comes to pain care or addiction to heroin and painkillers.

  14. Christina at 6:31 am

    We need to focus on how patients can’t even obtain medications there physician are perscribing. Due to the DEA threats and fear tactics they are imposing on pharmasict. Making them profile patients when they don’t know a damn thing about them. Who also do not posses the education about dieases or injuries that patients have. Making a patient plead there case to a pharmacist after there doctor to fill the medications. Which is not a pharmacist job to decide which in a lot of states is what is happening. Why DEA reform is needed and over looked year after year. They should be an organization that between DEA and pharmacist so that pharmacist can help patients without the fear of being arrested. Political parties are ruining pain relief for patients and their reason is drug abuse. The studies have show that there are other drugs or alcohol in their system when they overdose. Drug abusers will find what ever they can abuse it does not stop it by limiting medications. Allowing pharmacies to charge what ever they want for a medication and choosing not to except insurance is another mess that is not being dealt with either. Which are crocks hiding behind a business and is not frowned apone.