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Pressure grows on FDA to revoke approval of Zogenix's Zohydro

  • A group of over 40 healthcare, consumer and addiction-treatment advocates has sent a letter to the FDA urging the agency to withdraw its authorization of Zogenix's (ZGNX -1.8%) Zohydro opioid painkiller.
  • The latest move comes after 29 state attorneys general sent a similar letter to the FDA in December, while in November, members of Congress asked the agency to review the approval.
  • The fear is the potential for abuse that the narcotic pill presents, especially because of its high potency.
  • "It will kill people as soon as it's released," says Andrew Kolodny of Physicians for Responsible Opioid Prescribing.
  • Zohydro is set to become available in March.
Comments (38)
  • Jbgoose
    , contributor
    Comments (1055) | Send Message
     
    If only these folks were educated. It is completely irrational behavior for someone of such trusted public faith to make false blanket statement such as someone is going to die. Shame. How about the liver deaths? How about all the scrutiny and regs all will follow as livers are protected and patients are given a far LESS potent opioid to start with? Andrew- you are not correct and simply have an agenda. This agenda apparently ignores the facts. This agenda apparently is in line with populist politics and not doctors who will responsibly distribute such a needed non APAP solution for hydro- not a highly potent painkiller vs most of them- do your research.
    26 Feb, 11:18 AM Reply Like
  • mar4k
    , contributor
    Comments (2) | Send Message
     
    you are absolutely right, Andrew Kolodny is an irresponsible doctor acetaminophen poisoning is one of the biggest problems today adding billions to healthcare costs. The FDA has recognized this and is trying to stem this problem. Zohydro will be prescribed for people with serious uncuttable pain. I have a relative in the hospital who is 90 zohydro would be perfect for her and thats who zohydro is for not minor pain.
    28 Feb, 01:39 AM Reply Like
  • whtmtn
    , contributor
    Comments (17) | Send Message
     
    Why not push for the ban of oxy? Why limit this to one Company? Also, seems to me that other large drug companies may be pushing for this news. Check out Pfizer's release:

     

    "Pfizer Inc. (PFE) said its treatment for chronic lower back pain met the primary efficacy endpoint in a Phase 3 study.

     

    The drug maker's investigational agent ALO-02 is an oxycodone hydrochloride and naltrexone hydrochloride extended-release capsule meant to treat people with moderate-to-severe chronic low back pain."

     

    Do you think they have an agenda?
    26 Feb, 11:29 AM Reply Like
  • I Know
    , contributor
    Comments (6) | Send Message
     
    I work at Pfizer Inc. I can't say much. But it is true that the company has paid CNN and other various news sources a large sum to talk negatively about the formulation.
    27 Feb, 08:12 PM Reply Like
  • jennyfir
    , contributor
    Comments (2) | Send Message
     
    Of course they have an agenda. Hydrocodone is in numerous other painkillers on the market, percocet, vicodin etc etc. Competitors who finance these congressman have petitioned this ban, they have a lot to lose when Zohydro hits the market in March.
    27 Feb, 09:24 PM Reply Like
  • sethlemay
    , contributor
    Comments (198) | Send Message
     
    Let's revoke the use of vehicles. People will die.
    26 Feb, 11:32 AM Reply Like
  • jennyfir
    , contributor
    Comments (2) | Send Message
     
    I know seriously. I'm about to OD on 3 gallons of water, let's ban it.
    27 Feb, 09:24 PM Reply Like
  • sethlemay
    , contributor
    Comments (198) | Send Message
     
    Am I the only one who thinks Zogenix should issue a statement in terms of efficacy and safety. I don't understand how this is any different than Oxycontin which is proven to be much more addictive than Hydrocodone. I doubt they revoke if for no other reason than the FDA is pretty bull headed once they make a decision either for or against.
    26 Feb, 11:59 AM Reply Like
  • Street Instincts
    , contributor
    Comments (95) | Send Message
     
    http://bloom.bg/1frMVcJ

     

    Stupid rules are the theme of the day.
    26 Feb, 12:02 PM Reply Like
  • Jbgoose
    , contributor
    Comments (1055) | Send Message
     
    Exactly- I'm not going to knock down oxy- but I will point out it is about 150% more potent on most morphine equivalent studies... Which is only 30ish percent absorbed to begin with vs oxy which acts in many within 20 minutes, well. Far more potent than hydrocodone. And in formulations far more potent than Zohydro. And currently about the best option for many in real pain which taken regularly leads to .... ? We know. It is a far more effective choice for many patients needing stronger medicine. Let's ban all you can eat nights at Olive Garden or the local pub because they might make some people over eat mercury laden shellfish or gosh forbid use canned beets and acidic veggies that eat away at the bpa lined cans, then leached into the food via lined take out containers and such, or gosh forbid put something like bacon bits on a salad with blue cheese dressing, preservatives or - gasp - fast food, ice cream at the beach, oh no, that's a certain immediate death. This guy needs to be put in his place.
    26 Feb, 12:06 PM Reply Like
  • Jbgoose
    , contributor
    Comments (1055) | Send Message
     
    Not leaving the debate but I had to pull the trigger up approx 110% overall. These political noisemakers are simply driving a runaway train to elections. I say we subject them to the scrutiny legit patients are subject to every 3 weeks - and make them pay the bills for all the misdirected urine tests and soviet era style probes people with chronic illness already face. This should be a lawsuit straight up. On what grounds- how about defamation to start - anyone prescribed these Meds are now outcast. Who will hire someone taking zohydro? It's ok if you need Prozac but not ok if you need pain control? Please...
    26 Feb, 02:47 PM Reply Like
  • sethlemay
    , contributor
    Comments (198) | Send Message
     
    Damn, I was actually thinking this was a one day thing and thinking about buying more.
    26 Feb, 03:33 PM Reply Like
  • sethlemay
    , contributor
    Comments (198) | Send Message
     
    Unless more and more news comes out I was pretty sure it was temporary
    26 Feb, 03:34 PM Reply Like
  • Jbgoose
    , contributor
    Comments (1055) | Send Message
     
    I do hope to re enter the trade- looking at other options for a quick trade in a non bio related play, for a trade, then will see where things stand with ZGNX. They need to get over 5 and stay, increased institutional ownership in terms of the number of funds holding. Then once the scripts start coming in from institutional settings first, as we all know is most likely where the tonnage is... Watch the stock take off, or perhaps a deal? Triggers are either way, and none involve abuse nor 'bad medicine' - this must be the closest watched launch in class. And to think t gel is still advertised, let's go to that tropical island and debate it Mr. Kolodny. What is the correct prescribing guideline for your book with that?
    4 Mar, 06:40 PM Reply Like
  • sethlemay
    , contributor
    Comments (198) | Send Message
     
    86% isn't enough institutional holding? What makes you think think the majority shareholders want to let more institutions in on the action.
    4 Mar, 06:46 PM Reply Like
  • Jbgoose
    , contributor
    Comments (1055) | Send Message
     
    Hey Sethlemay - One can twist percentages so many ways that one can make a career out of it. I like more diversity in the top ten to hold the more matured and followed bio niche plays. In English, I'm saying I usually, but not always, don't like it when the top five hold about everything. With ZGNX it actually has helped, in my opinion. They need a solid few sales reports and signs of traction with compliance in unparalleled ways. Then it's a nice ride with target date or aggressive strategy, healthcare oriented multi cap or micro index funds pouring in auto cash and it makes percentages even better.

     

    http://yhoo.it/1c7hbJ5
    4 Mar, 11:31 PM Reply Like
  • celestinafast
    , contributor
    Comment (1) | Send Message
     
    This is a needed Drug!
    26 Feb, 06:06 PM Reply Like
  • petebmd
    , contributor
    Comments (3) | Send Message
     
    Look, we all know that there are drugs more potent and more powerful than Zohydro. I know this first hand because I am employed at an interventional pain clinic. The constant bashing of Zohydro is just noise. At the end of the day, this drug is absolutely needed despite what people with NO PAIN have to say.
    26 Feb, 08:59 PM Reply Like
  • 12579611
    , contributor
    Comments (9) | Send Message
     
    There is clearly an agenda here. Hydrocodone is much less potent than OxyContin, hydromorphone, oxymorphone, fentanyl, or methadone. This will be the first line long acting pain med prescribed, which means there will be less oxycodone scripts written. Of course, if you have an agenda it doesn't matter if a weaker painkiller will be taking the place of a stronger one.
    26 Feb, 09:06 PM Reply Like
  • ScottyGreen
    , contributor
    Comments (86) | Send Message
     
    What is irritating to me is when the press writes about it being "super mega potent" etc etc, when it's an extended release. It HAS to be stronger to last more hours, but they only refer to total mg. They compare apples to oranges all the time.

     

    They act as though the pills are just going to jump out of the bottle and strangle you if you look at them wrong or something. Fear based hype imo.

     

    As far as FDA is concerned, IF they were to reverse their decision (they won't) it would set a tone that any "group" can get a drug pulled and question fda approvals from here on out, and I highly doubt the FDA wants to battle every time they approve a drug with the slightest bit of controversy involved.
    27 Feb, 12:01 PM Reply Like
  • idontwantto
    , contributor
    Comment (1) | Send Message
     
    What about the people who need this option. They have no choice. The people abusing this stuff do have a choice.
    27 Feb, 01:31 AM Reply Like
  • KillTheMessenger
    , contributor
    Comments (3) | Send Message
     
    Zohydro is going to save lives and improve the lives of millions of chronic pain sufferers. All drugs are subject to abuse. Zohydro will launch next month, there is nothing a handful of anti opioid crusaders can do about it.
    27 Feb, 01:31 AM Reply Like
  • czacza
    , contributor
    Comments (2) | Send Message
     
    This sounds like a jealous move for other big pharmas to protect their market share - SO OBVIOUS pfizer, teva, abbievie, purdue -
    27 Feb, 01:40 AM Reply Like
  • czacza
    , contributor
    Comments (2) | Send Message
     
    Sounds like a jealous move from big pharma. SO OBVIOUS (hint: pfizer, teva, purdue, abbievie - back off)
    27 Feb, 01:40 AM Reply Like
  • Muse94552
    , contributor
    Comment (1) | Send Message
     
    Those who want to interfere/stop Zohydro apparently have no concern about the debilitating daily pain that so many cancer and other patients endure. The onging suffering of genuine legitimate patients is imposed by the no-drugs crew in an effort to prevent some maybe-abuser from maybe overdosing.
    What a twisted and cruel point of view.
    I would LOVE to see Zohydro available to legitimate patients; this drug may even reduce the requests for assisted suicide- often triggered by unmanaged pain.
    27 Feb, 01:57 AM Reply Like
  • sethlemay
    , contributor
    Comments (198) | Send Message
     
    I would like to hear ZGNX come out with a press statement, but I really don't think they will. A whopping 86% institutional ownership says they aren't reliant on retail investors to stay afloat. How many times in history hast he FDA revoked approval in a scenario like this. I imagine it hasn't happened many times.
    27 Feb, 09:44 AM Reply Like
  • sethlemay
    , contributor
    Comments (198) | Send Message
     
    $ZGNX probably isn't concerned 86% institutional ownership says there won't be a big sell off. Smart money is smart for a reason.
    27 Feb, 09:53 AM Reply Like
  • Jbgoose
    , contributor
    Comments (1055) | Send Message
     
    I still believe the true story. And as an irrelevant retail holder have to book and move on with this trade. Though I was hoping to ride it thru a few sales reports. Plenty triggers thirty days from now. Much needed medication for many uses and facilities. Facts well known to those in healthcare and all impacted or interested patients. No question there. These noisemakers agenda is to obscure the truth, and the changed problems they now face since about 2009 when pills crossed over with opioid street drug use doubling. They ask, why put another compound out there, well- nobody is doing that. This medication will save lives, not destroy. Unfortunately this is lost upon crusaders who could help if focused on treatment.
    27 Feb, 10:38 AM Reply Like
  • sethlemay
    , contributor
    Comments (198) | Send Message
     
    I think that perhaps the price has taken the brunt of the news already, but who knows. It all depends on how much print the media can drum up.
    27 Feb, 10:41 AM Reply Like
  • Jbgoose
    , contributor
    Comments (1055) | Send Message
     
    My concern is they have yet to break then hold five. Further downside than upside re a trade until those first few sales reports and field results come in. All far out from now. So- where does that leave the trade, barring a buyout or leap in the other products, partnerships.
    Had to be prudent. Emotions aside... But if those reports look remotely good, as this first line ER pain pill looks promising to all who know the truths; with PTIE, PFE, Teva, a dozen others... seem to be moving into the first line moderate to severe IR and ER space for a decade/ issue being ART effectiveness vs current generics and obviously then costs. No reason why a patient should pay hundreds for what should be pennies.
    27 Feb, 09:13 PM Reply Like
  • gnebee4
    , contributor
    Comments (2) | Send Message
     
    So, does this mean Vicadin the most widely prescribed pain med with Tylenol would have to come off the market too as Zohydro is basically the same thing less tylenol? If that's the case, street corner value on Vicadin just blew the price of ZGNX stock away. Before heading to so much as a dentist, one would be heading to a street corner "vendor" for their pain killer? Now that is absurd! The screamers haven't thought through this very well now have they and most definitely have not lived with chronic pain.
    27 Feb, 04:43 PM Reply Like
  • Mark S. Anderson
    , contributor
    Comments (19) | Send Message
     
    This article is extremely misleading. How is the strength of the drug left out? IT IS THE MOST IMPORTANT THING! Here is an equianalgesic chart. http://bit.ly/NAEoYU
    Oxycodone is almost twice as strong as hydrocodone so there is a much weaker drug being put on the market as a substitute. The groups need to pay attention to a better alternative.

     

    Hydrocodone can be habit-forming, causing physical and psychological dependence. Its abuse liability is similar to morphine and LESS than oxycodone. It is is similar but still less than.

     

    should be embarrassed for leaving out two critical pieces that are the most important elements of the story.
    27 Feb, 08:15 PM Reply Like
  • Jbgoose
    , contributor
    Comments (1055) | Send Message
     
    Morphine scares people... Only 30ish percent is even absorbed in pill form and oxy is far more 'addicting' as stated above. It is most certainly not a medicine to mess with of course. It does work well systemically. But just as these people who make noise have no idea what a stock index ETF is, most have no idea about bio equivalent nor pain control, REMS - they put a blanket stereotype on all people and for some reason, pain is weakness. Compared to a mental lapse such as that intern given booze at the company party, that's just all good fun. Really, by all means, chomp down any medicine that turns a cubicle dweller into a laser focused machine, like all ADHD Meds can, and that is totally fine. An exec taking heart Meds to relax prior to a speech, the shot of customary bourbon as I have seen, totally fine. A pill that helps one productively live through herniations, RA, so many conditions- that's a pain pill, weakness, failure. The psychology is unique.
    27 Feb, 09:26 PM Reply Like
  • Mark S. Anderson
    , contributor
    Comments (19) | Send Message
     
    Here you go ZGNX http://bit.ly/1kg0mi3
    That's more accurate and informative.
    28 Feb, 08:05 AM Reply Like
  • mcmenamy1
    , contributor
    Comments (7) | Send Message
     
    zngx just expanded the sales force from 50 to 150 people. that's a good sign that others are worried about them taking market share. most companies don't hire 100 sales rep (typically making at least $100k, prob more with bonuses) if they aren't planning on creating real and sustainable revenue.
    28 Feb, 04:57 PM Reply Like
  • Mark S. Anderson
    , contributor
    Comments (19) | Send Message
     
    By: John Lavitt

     

    Key FDA staffers and scientists (the FDA has a large science research staff that handles analysis of new drugs) have been instructed not to talk directly with the press – a fairly standard practice. Calls from The Fix to specific staffers were referred to the FDA press office. After prodding by The Fix, that office responded to a series of our queries although it did not permit direct interviews with staff members.

     

    First, the office made a point that the FDA “encourages” tamper proofing but doesn’t require it because the science is imperfect and differs with each pain-killing formula. Its practice has been to use FDA authority to withdraw drugs after there is sufficient reason to do so and based on a cost-benefit evaluation.

     

    As example, FDA spokesperson Morgan Liscinsky noted in an email that accumulated evidence led the FDA to require that the original formulation of OxyContin be withdrawn from sale by generic manufacturers “for safety or effectiveness reasons.” She added: “Reformulated OxyContin can be expected to make abuse via injection difficult and to reduce abuse by snorting compared to original OxyContin.”

     

    In other words, once there was a more abuse-resistant Oxy available, the FDA decided it could ban the original formula. No matter how many deaths from or addiction to and abuse of Oxy occurred earlier, the FDA was loathe to ban it earlier because of its widespread use as an effective painkiller.

     

    By stark contrast, the FDA also investigated another time release painkiller, Opana ER. It got a pass. As Liscinsky emailed: “In May 2013, the FDA concluded that while reformulated Opana ER and original Opana ER have the same therapeutic benefits, there is insufficient evidence that original Opana ER poses an increased potential for abuse compared to reformulated Opana ER.”

     

    Ergo: lacking sufficient proof of damage done by Opana ER, the FDA left the original on the market.

     

    And why did Zohydro also get a pass? What is the meaning of the statement that the FDA “could notnot approve it?”

     

    According to Liscinksy, “Zohydro met the same safety and effectiveness standard” with the same “risk-benefit profile” as other hydrocodone painkillers already on the market, none of which have developed effective abuse resistant formulas.

     

    Translated, Z is not worse than anything else out there and, Liscinsky added, the FDA concluded its benefits for patients in pain outweighed the risks of additional addictions and abuse. Accordingly, the statement “could not not approve it” meant there were no compelling scientific, medical or legal reasons by which the FDA could allow similar drugs on the market and ban Zohydro, especially since Z will add a unique element to the pharmacy: long term relief from a hydrocodone with no liver-damaging acetaminophen in it.

     

    The Fix pointed out to Liscinsky that, working with the same data sets, the advisory panel concluded that, owing to Zohydro’s potency and “single entity” qualities, more deaths and drug abuse would occur as clever addicts made a beeline for Zohydro. Even in closely monitored clinical trials, people became addicted to the drug and found ways to obtain it illegally; some patients even died from overdose. Moreover, the advisory panel, which included treatment experts, concluded that all the new monitoring regulations “will at best be modestly effective in addressing the public health issues of opioid abuse.”
    28 Feb, 10:40 PM Reply Like
  • Mark S. Anderson
    , contributor
    Comments (19) | Send Message
     
    I saw a couple places that state it is launching tomorrow. I would think it would be posted on Zogenix's website so I am unsure of the validity.
    28 Feb, 10:41 PM Reply Like
  • gnebee4
    , contributor
    Comments (2) | Send Message
     
    A message from the CEO of Zogenix to our stakeholders:

     

    An increasing number of news reports have been including false and misleading statements about our company and our product, Zohydro™ ER (hydrocodone bitartrate) extended-release capsules (CII), the first and only extended release hydrocodone product without acetaminophen.

     

    This misinformation has created negative perceptions about Zohydro ER, which was approved by the FDA in October 2013 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Up to 2.4 million patients who are currently taking immediate-release hydrocodone with acetaminophen for management of their severe chronic pain may be at risk for liver damage due to acetaminophen, which can be fatal or require a liver transplant. Zohydro ER serves as an important option for those patients, as well as providing an alternative option for severe chronic pain patients who have developed opioid tolerance, are not getting optimum pain relief or are experiencing side effects with other long-acting opioids.

     

    Critics of Zohydro ER have claimed that this treatment is 10 times stronger than other opioids, 10 times more “lethal” than other hydrocodone prescription drugs (none of which are extended-release formulations), and that this is the strongest opioid available. All are gross misstatements and fail to consider each of the very different FDA-approved indications of each product and do not acknowledge that these products are used to treat a different severity of pain as reflected by their individual prescribing labels. The fact is, there are other extended-release opioids which are of higher strengths than Zohydro ER. For example, the highest dosage unit of extended-release oxycodone is 80 mg and the highest dosage unit of extended-release morphine is 200 mg, both of which are substantially higher than the highest dosage unit of Zohydro ER (which ranges from 10 mg to 50 mg).

     

    In reality, any drug that is not used as prescribed presents a danger to the person abusing the medicine. That is why we have taken extraordinary steps to support the appropriate use of Zohydro ER through a comprehensive set of industry-leading safeguards. Before we even launched Zohydro ER, we established an External Safe Use Board of experts, including pain management, addiction and law enforcement specialists, who will independently evaluate surveillance data which will be continually shared with our Board of Directors and the FDA.

     

    In addition, unlike other pharmaceutical companies, we compensate our sales team not on sales of Zohydro ER, but on their educational efforts and utilization of educational resources by prescribers, pharmacists and patients. We also provide access to free locking pill bottle caps and discounted safe-storage units to support appropriate use of Zohydro ER within the home.

     

    We further would like to note that without justification, inaccurate allegations have been made that Zogenix paid a university to arrange meetings with the FDA to secure approval of Zohydro ER. The university in question has declared for the record that, in the meetings it arranged with FDA officials, no representation from Zogenix was present, nor was the company or its products ever discussed. In fact, Zogenix did not even exist as a company at the time of these meetings.

     

    On behalf of severe chronic pain sufferers who will potentially benefit from Zohydro ER, we will continue to move aggressively to correct these false and misleading statements. The plight of people living with severe chronic pain should not be politicized. We encourage representatives of the news media who are reporting on Zohydro ER to contact us directly and we will gladly share the facts.

     

    Roger Hawley
    Chief Executive Officer
    20 Mar, 07:00 PM Reply Like
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