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States ask FDA to reconsider approval of Zogenix painkiller

  • More than two dozen state prosecutors send a letter to the FDA asking the agency to reconsider its approval of the new Zogenix (ZGNX +3%) painkiller Zohydro, saying the narcotic pill could add to the national epidemic of prescription drug abuse.
  • The FDA approved Zohydro in October, making it the first single-ingredient hydrocodone drug ever cleared for U.S. patients; the pill uses an extended release formulation reportedly 5x-10x more potent than currently available hydrocodone combination pills such as Vicodin.
  • ZGNX has said it is working on a version of the drug that is more difficult to abuse.
Comments (10)
  • Clayton Rulli
    , contributor
    Comments (2993) | Send Message
     
    Hey guys lets approve yet ANOTHER pain killer but lets put Lemtrada under a microscope!
    12 Dec 2013, 02:21 PM Reply Like
  • ScottyGreen
    , contributor
    Comments (103) | Send Message
     
    It's actually a step in the right direction if you knew anything about the drug and why it's important in this formulation.
    12 Dec 2013, 02:37 PM Reply Like
  • ScottyGreen
    , contributor
    Comments (103) | Send Message
     
    it's an extended release tablet, it has to be more "potent" to spread out the dosage over an entire day. gotta love fear based journalism garbage. FDA took ALL things into consideration when they approved and stand behind their approval 100% Zogenix is also working on a second formulation with abuse deterrent to play nicey-nice with all the skeptics/naysayers. This drug is very much needed by docs/patients b/c no acetaminophen/liver damage and doc surveys are positive.
    12 Dec 2013, 02:29 PM Reply Like
  • Txexrx
    , contributor
    Comments (2) | Send Message
     
    I am a pharmacist in Texas. I have a doctorate in pharmacy and phd in nuclear medicine. I am board certified in three disciplines, one being pain management, but more importantly I have 25 years experience in the retail pharmacy practice. Mr. Green is correct in that it would provide significant relief to many suffering from chronic pain. But the unfortunate truth is that this drug would become an overnight sensation in the world of abuse. It is already known that a capsule can be dissolved in alcohol in order to receive the full dose of hydrocodone immediately. Especially now that oxycontin has a formulation that's impossible to abuse (compared to the original and previous formulation), there is nothing else (oxycodone 30mg would be closest rival) to compare. One capsule would be cheaper than five or ten hydrocodone combination tablets, so cost is no consideration in this world. It would, indeed, offer pain relief to legitimate patients, but because the certainty of widespread and epidemic abuse this drug cannot be allowed on the market. Purdue will be introducing a formulation of hydrocodone that will be delivered in the same non-abusable tablet formulation as their new Oxycontin, and that's merely months away. So there will be the hydrocodone only product so desperately needed by chronic pain patients. Zohydro will be one of the most unfortunate chapters in the history of new drugs, if it reaches the market. And if it does reach the market, it will be recalled almost immediately once what I've described is realized. I'd buy stock, except for I am intimately familiar with this industry.
    12 Dec 2013, 04:08 PM Reply Like
  • Brwood6980
    , contributor
    Comment (1) | Send Message
     
    "OxyContin has a formulation now that is impossible to abuse" haha! wow! talk about someone who thinks they know everything and actually knows NOTHING! We're all very proud that you can read books and pass tests for your doctorate degrees but the truth is, your head is in the sand. Both OxyContin and hydrocodone will continue to be abused and people will continue to die. But the fact of the matter remains, these people don't care if they live or die and CHOOSE to abuse. whereas pain patients have no choice. They NEED a drug without acetaminophen and zohydro gives that to them. No way in hell this product gets taken off the market. FDA knew there would be backlash when they approved. Well here is the backlash. They're ready for it.
    13 Dec 2013, 01:33 AM Reply Like
  • coyote88
    , contributor
    Comment (1) | Send Message
     
    It's amazing how ill-informed the prosecutors/politicians are on matters like this. They actually care more about the idiots that want to abuse these drugs and kill themselves, than the people that REALLY NEED this type of prescription drug. I have rods, screws, and cages holding my spine in place, and have had to take pain medications for eleven years now. I have seen numerous doctors in three states because of the pain and the gradual loss of my legs because of the pain, and they all have agreed that I will be on pain meds for the rest of my life. I will continue to have to take hydrocodone for the rest of my life, which means there is a very REAL CHANCE that the acetaminophen will eventually KILL MY LIVER. With the approval of Zohydro I will NO LONGER HAVE TO WORRY ABOUT DYING FROM LIVER & KIDNEY FAILURE. Now, which sounds more reasonable, keeping this drug on the market so people such as myself can LIVE, or taking it off the market so "abusers" can live? I don't want to die from liver failure, and the abusers don't give a damn whether they live or not, so WHY would anyone even consider taking this back off the market'
    12 Dec 2013, 04:09 PM Reply Like
  • ScottyGreen
    , contributor
    Comments (103) | Send Message
     
    I feel for you coyote88 and hope you find something.

     

    **People (not the above) are missing the fact that this drug will not just be prescribed in family/private practices, but in easy-to-monitor HOSPITALS/NURSING HOMES/REHABILITATION CENTERS. Monitoring a patients intake is MUCH easier in places like this because nurses watch you take your meds and keep them locked away out of a patients/or dubious abusers reach.

     

    Now tell me that isn't a giant market that can be closely monitored with very low chance of abuse?

     

    The docs and nurses I've spoken to in a hospital and rehabilitation center, WANT this drug yesterday.
    13 Dec 2013, 10:39 AM Reply Like
  • ScottyGreen
    , contributor
    Comments (103) | Send Message
     
    Forgot to mention, my brother in law is a regional sales manager for a very large and well known big pharma company, and he said he would jump at the chance to market this drug because of it's huge profitability potential. long zogenix all the way here folks!
    13 Dec 2013, 11:14 AM Reply Like
  • davidoster
    , contributor
    Comments (5) | Send Message
     
    Too bad this brief news blip failed to tell the entire story. The AG's did not only ask the FDA to reconsider the approval of Zogenix. They also asked the FDA to "or basically help Zogenix fast-track the development, approval, and release of Zogenix's abuse deterrent formulation." Zogenix is working hard to get an AD formulation approved and in fact are working it on two paths. They are working with Atlas and Alkermers.

     

    This news really help Zogenix and is positive in that regard
    12 Dec 2013, 10:47 PM Reply Like
  • Jbgoose
    , contributor
    Comments (1675) | Send Message
     
    The ignorance is no longer shocking, yet stings every time. The AG's might want to enforce laws in place rather than tell doctors and patients how to manage private health matters. Ever look at the labels, side effects for weight loss drugs? Why don't these AG's tell people to glue mouths shut and shrink a waste via starvation rather than diet and lifestyle changes? What would public reaction be to that? More Americans face obesity than not. But that's 'different' somehow? How about the unknown impact of Neurontin, Lyrica, Lexapro, Prozac, Ativan, Alcohol, on and on? Many mentioned can cause horrid birth defects (anyone not a DR try to guess which, like these AG's). Yet because of this hysteria and political slant many younger folks are readily prescribed such meds at will and it's somehow totally accepted regardless of patient age and potential for tragedy. I educated an Ivy League neurologist after he tried to get me on Neurontin as we were having children (3 months to start and stop). He was shocked how uneducated he was about the dangers and switched sides right fast - all would agree that's a scary thought. However, in reality it was simply a lawsuit waiting to happen that was avoided, that is always the true fear, most care less about a few birth defects vs lawsuits? Maybe that is the truth? Honestly folks, man up and stop this political self promotion, stop the spread of false information and needless panic. In NO way could Zohydro be made available for such widespread distribution causing any such destruction and abuse- it is simply not possible if AG's enforced current laws to begin with. SHAME on them. The reality is patients face discrimination, are the true victims of said abuse and must rise above these headline seeking politicians. I do hope davidoster is correct. Go ahead and bash away. To the families of people who put a needle in their own arm, by their own fault, their own actions, I truly am sorry for your suffering, it's happened to my extended family and I get it - but don't tread on me and other patients! Why as stated above are we protecting such people? The liver deaths are an epidemic. It is insane to me and so many others this is so controversial. Hydrocodone itself is a tried and true medication, the most prescribed thus most easily studied. We KNOW about the massive costly problems when combined with 'APAP' so why continue down that path? SHAME. This country has to wake up. Fact is people are aging, having procedures and are in treatable pain, the use of meds will rise so it is what it is, simple statistics. Gee Whiz. Back to my tense unit for electric shock therapy at such an hour of night, bless all who suffer
    13 Dec 2013, 01:59 AM Reply Like
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