Federal Judge Asked to Lift Ban on Zohydro

Federal Judge Asked to Lift Ban on Zohydro

An unprecedented ban on a controversial new painkiller remains in effect in Massachusetts, after a federal judge in Boston heard arguments in a lawsuit by drug maker Zogenix (NYSE:ZGNX) asking for a temporary restraining order that would allow Zohydro to be prescribed and dispensed in the state.

There was no indication when federal Judge Rya Zobel would rule on the case. Last week Zobel indicated she might overturn the ban, saying,“I think that, frankly, the governor is out of line on this.”

ZOGENIX, INC. CHARTS, GRAPHSLast month Gov. Deval Patrick declared a public health emergency in Massachusetts over the “growing opioid addiction epidemic” and ordered the ban on Zohydro, the first pure hydrocodone painkiller sold in the U.S. Some addiction treatment experts have claimed the new painkiller will fuel a new wave of narcotic abuse and overdoses.

“Imagine 50 states each imposing a different formulation requirement,” Zogenix attorney Stephen Hollman said during a brief hearing Monday, arguing that individual states do not have the authority to restrict a drug approved by the Food and Drug Administration.

“Congress’ intent was clear. It directed the FDA to promote public health by exclusively approving safe and effective drugs,” Hollman said.

Massachusetts Assistant Attorney General Jo Ann Shotwell Kaplan said states do have the right to regulate drugs and said FDA approval is “not a guarantee that they get to market thereafter in every state.”

Kaplan said she was not aware of any other state banning an FDA approved drug, but said the Zohydro case was unusual because the agency approved Zohydro over the objections of its own staff and advisory committee, which warned the painkiller could be abused even more than currently available hydrocodone products.

In recent months, addiction treatment experts, several congressmen and the attorneys general from 29 states have asked the FDA to reconsider its decision to approve Zohydro, claiming the painkiller was several times more potent than other hydrocodone drugs.

The American Academy of Pain Management (AAPM), which represents over 4,300 healthcare providers in the field of pain management, released a statement in support of Zohydro, saying there was “hysteria over its abuse potential”.

“The Academy believes that banning Zohydro is not the right solution. Doing so would unfairly penalize the vast majority of individuals for whom it would be prescribed, in the service of protecting those relative few who would choose to use it inappropriately,” the AAPM said in the statement.

“We recognize the likelihood that Zohydro will be misused, abused, and/or diverted by individuals whose motives are other than the intended use of the product. In this sense, it is no different than any other opioid analgesic, immediate release or extended release, on the market.”

Authored by: Pat Anson, Editor

There are 11 comments for this article
  1. Dennis Kinch at 11:53 pm

    Methyl.C – it’s always the point that gets lost in the semantics. Dangerous is dangerous. Do people die from withdrawal or from the strain on their heart? Whether your facts and figures are right, or my observations are more correct, do you want to be the guinea pig? Doctors should know better.

    They use semantics all the time to prove their point. We are warned ad-nauseum of side effects even though most are one in a million occurrences. We are made to follow insane rules because a huge minority of addicted users are over dosing, for the sake of some do-gooder politician or DEA agent’s semantics.

    So please, try to see through my semantics for a minute and imagine being told you won’t have pain meds for a month through no fault of your own. This is the point. When I go through withdrawal (4 times last year due to these stupid rules) maybe I won’t die from it, but I’m usually hoping to.

  2. Methyl.C at 9:59 pm

    “Someday, when a patient dies from sudden withdrawal, a legit patient who had no control over the outcome, and everyone involved gets sued for millions, maybe then they will start thinking. Why no one is thinking of this now, I really don’t understand.”

    I really don’t understand what you’re getting at. Opioid withdrawal syndrome is fairly well understood. First of all, it is rarely fatal under normal circumstances even with no medical assistance (highly uncomfortable yes, fatal no). Withdrawal from alcohol, barbiturates, benzodiazepines, is far more serious: especially the seizures, coma, death parts which are virtually unheard of during opioid withdrawal.

    Secondly, opioid withdrawal isn’t typically ‘sudden’. Symptoms develop gradually as the substance wears off, so when they will start to develop depends on the half-life of the opioid used. Half-life also correlates with the length of the withdrawal period.

  3. Dennis Kinch at 1:27 pm

    Someday, when a patient dies from sudden withdrawal, a legit patient who had no control over the outcome, and everyone involved gets sued for millions, maybe then they will start thinking. Why no one is thinking of this now, I really don’t understand.

  4. Trudy McGee at 7:07 am

    I recently had my monthly supply refilled, and I was robbed. I filled out a police report, took it to my pain doctor and I was DENIED any replacements. I am now being punished for something that I had no control. Even drugstores, (those that have trust in you for the moment), will give you one exception of filling pain meds with a police report!! I am so angered!! I now have no pain meds and am being punished, while the person who stole them is NOT being punished!! They know who it is, but since the meds are gone, how can this be proved?? Why is this country coming to this?????

  5. Pauly at 6:12 pm

    I agree with you totally Stephen. STOP THIS HYSTERIA OVER OPIOIDS!!! Its INSANE!!!! Two Zohydros are NOT going to kill someone! The people spreading these rumors are misinformed. Stop spreading lies!

  6. Dave at 11:28 am

    Mr. Twillman- Thanks for clarifying that you are not the AAPM that was under federal investigation. My apologies for my error.
    I would like to point out that Zohydro- like other opioids may be abused by well intentioned people in pain, as well. Given Franklin’s law you cannot predict a persons response to an opioid. Even with “functional pain genomics” predicting any one individuals response to taking any opioid remains unpredictable.
    People may still become addicted to opioids who have no intention of becoming addicted. You also have the problem of pseudo- addiction.
    Frankly, the public good would be better served by calling for more optimal treatments than opioids- it is not just a question of misuse for even with proper use opioids are suboptimal treatments, at best, with an ever growing list of side-effects- such as recent research on depression and opioids suggest. Finally, although some research shows that opioids can be used like Ketamine to prevent wind-up -remarkably they are not being used in that manner. They are being used to foster an indefinite dependency on a suboptimal treatment and ultimately the “opioid economy” deprives the public of having access to more dynamic and hopeful treatment regimens.

  7. Dennis Kinch at 9:41 am

    Without the numbers this is all speculative opinion, and we all have one. My guess is the numbers, as usual will show a huge majority of people are legit patients, under a doctor’s care and guidance and would never abuse drugs, ever! The very small minority are non-patients, illegal users who do very bad things to abuse their bodies.

    I’ll bet the media and the other fear mongers are right now scaring the sh__ out of people causing more patients to believe they’ve become addicts, more soon to be, legal users afraid to even try it for pain, and the bad people don’t read, so they will keep being bad and screwing it up for the rest of us.

    No one seems to understand what constant, chronic, permanent pain is like. We see these stories over and over again yet people still opinonate. Pain is like a fire, burning you all the time and it desperately needs water. Who among us wants to be on fire and be told, “Sorry, no water til” we hear from the governor.”

    Patients have to first, bring the level of pain down to a certain point in order to begin other pain treatments like PT and alternative medicines. The immediate treatment should be thought of as an emergency, as trauma, needing attention right now with anything that works.

    Let’s opinionate after we treat the immediate need. Let’s legislate using the majority numbers and deal with the minority afterwards. Lets separate the legal from the illegal and reward the legal users with immediate attention and care and let the police deal with the illegals. Let’s stop letting fear dictate our behavior and start letting behavior dictate our laws! And for God’s sake. let’s do it QUICK!

  8. Bob Twillman at 7:30 pm

    In response to “dave”: No, this is not the same AAPM that was under investigation. That was the American Academy of Pain Medicine; this statement comes from the American Academy of Pain Management. Roughly 40% of our members are those who specialize in non-pharmacological treatments for pain. Please read the last section of the statement–it emphasizes exactly what you are asking for as the way to get out of the opioid mess we are in.

  9. paula Artopiades at 6:03 pm

    I myself would welcome something like this. I live my days and nights in awful pain. I have bone on bone knees and severe athritis in each, all resulting from meniscal tears brought on thru the damaging effects of chemo for hodgkins disease, when i took 160 milligrams of prednisone each day. This was followed by a burst appendix due to a carcinoid tumor that formed either during chemo or was in there a long time and was aggravated to the point of bursting my appendix. I became of course septic, i got staph in the hospital and bactaremia, and c-diff, blah blah, in short I nearly died. When i came home over a month later I took with me an enormous incisinal Hernia and septic athritis in my knees. my spine was also affected and i have constant sciatic pain down the back of my legs, I am only 54. Due to people abusing opiates, i can no longer obtain them from my regular internist. Can you imagine what i go through each day ? And then going to different pain management drs. who have been tricked by so many claiming to be in pain who aren’t? My life is hell due to this. I don’t drink, I stopped smoking cold turkey when i got Hodgkins disease at age 42. I no longer know what it is to live in a life w/o pain. I take advil / alive every 6 hours. Sometimes I have to hold back and not take it for a whole 2 days just to see if I will get fresh relief on the third day, but then I’m in such pain spasms that its very hard to get my body out of the mode of such pain. The anger I feel at people who take a pain killer for a kick is unexplainable, furthermore, I don’t understand it. My own Dr growing up used to prescribe tylenol #3 when I was a young girl with severe menstrual cramps. That prescription was only used for 2 or 3 days a month, and every 6 months i’d get a new one. Until Ibuprofen was invented and that was like a miracle for me. Never would i have imagined using those pills as a fun thing, I just never understood that type of behavior. I equate pain with pills so taking a pill with No pain is senseless to me – even WORSE is the fact that now they don’t like prescribing muscle relaxers, which are the one thing that helps my spasms from the sciatica, I don’t know how I would like this particular med, but i would be willing to give it a try.

  10. dave at 5:38 pm

    Is this the same AAPM which was under federal investigation for their role in opioids?
    The AAPM would serve people in pain better by improving the education of their members and make much better treatments then opioids available for people in pain. It is remarkable how willing medicine is to defend ancient treatments like opioids- despite their lack of long term effectiveness- instead of developing an inspiring vision and energetic plan to create the symbols of a new day for people in pain. It would seem that medicine continues to be more or less satisfied with the sorry state of affairs in pain care- i guess that is easier then breaking your head open to create a new day for people in pain.

  11. Stephen M at 5:32 pm

    I’m so sick of the constant hysteria surrounding opioids! I really hope that the judge sides with Zogenix.