Purdue pain pill gets priority review


The FDA grants Priority Review to Purdue for its tamper-resistant pain medication that competes with Zogenix's (ZGNX) Zohydro. The agency's review of the company's hydrocodone tablet should take ~six months.

Purdue's chronic pain offering is hard for abusers to crush so it makes it more difficult to snort or inject. The FDA has stated that Zohydro could be pulled from the market if another manufacturer gets an abuse-deterrent version approved. Zogenix plans to submit an sNDA for an abuse-deterrent formulation of Zohydro in October. Two other competitors are in Phase 3 trials with their product candidates.

Related tickers: (TEVA) (ABBV) (ALKS) (MNK) (PFE)

Comments (24)
  • Kastanes
    , contributor
    Comments (1289) | Send Message
     
    I doubt the FDA will pull Zohydro if the company plans to submit their abuse resistant formulation in October.
    8 Jul 2014, 07:49 AM Reply Like
  • PharmSterZzZ
    , contributor
    Comments (253) | Send Message
     
    FDA did not say that.

     

    (Reuters) - U.S. Food and Drug Administration Commissioner Margaret Hamburg on Thursday defended the agency's approval of Zogenix Inc's Zohydro, saying the powerful prescription opioid offered a "unique" option to help treat pain.

     

    Hamburg, responding to a query from a U.S. lawmaker, said that currently approved hydrocodone drugs also contain acetaminophen, which can be toxic to the liver at higher doses. Zohydro does not contain the added pain ingredient.

     

    "We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy," Hamburg said at a hearing of the Senate's Health, Education, Labor and Pensions Committee.
    1 Aug 2014, 04:41 PM Reply Like
  • jlaine
    , contributor
    Comments (2) | Send Message
     
    Biotech run-up investor. Holding Biotechs 1-3 months prior to the catalyst date.
    8 Jul 2014, 08:37 AM Reply Like
  • jdadyfinance
    , contributor
    Comments (238) | Send Message
     
    This just in... Reports indicate a comet could strike the Earth !
    8 Jul 2014, 08:59 AM Reply Like
  • Street Instincts
    , contributor
    Comments (102) | Send Message
     
    I have yet to see evidence that ZoHydro has any abuse potential to begin with.
    8 Jul 2014, 09:48 AM Reply Like
  • rnn
    , contributor
    Comments (655) | Send Message
     
    Most have sold after the large run already, now we have bad news,so the greedy and getting smacked.
    8 Jul 2014, 10:34 AM Reply Like
  • Kastanes
    , contributor
    Comments (1289) | Send Message
     
    Please provide the link to back up your statement the FDA could pull Zohydro off the market.
    8 Jul 2014, 11:14 AM Reply Like
  • andyrewjohn
    , contributor
    Comments (9) | Send Message
     
    The FDA has defended Zohydro and its approval. The FDA is nowhere near even considering removing Zohydro. Just another hype article.

     

    http://reut.rs/1jbyoET
    8 Jul 2014, 11:19 AM Reply Like
  • Joe McCann
    , contributor
    Comments (261) | Send Message
     
    I actually wrote my first SA article on a potential pathway the FDA has used in the past to pull Zohydro off the market. Since that the time the FDA has been extremely vocal in the support of Zohydro. I'm not sure I've ever seen the agency be so proactively supportive of an already approved medicine. (I'm also not sure that I've seen them so attacked.)

     

    From this link:
    http://1.usa.gov/1ogScmw

     

    The FDA commissioner herself posted a lengthy blog describing her views including this very specific passage:
    "Some have asserted that this drug’s approval should have been delayed until it had an abuse-deterrent formulation. Unfortunately, this puts too much faith in the current state of abuse-deterrent technology, which is still in its infancy and has yet to be fully tested in actual market or use conditions. Even the abuse deterrent properties of Oxycontin, the only opioid with an abuse-deterrent claim in its labeling that is consistent with the approach described in FDA’s 2013 draft guidance on this topic, are limited. For example, while the formulation is designed to make abuse by injection more difficult, it doesn’t prevent it and there is nothing barring someone from taking more Oxycontin pills by mouth – the most common form of opioid analgesic abuse. "

     

    My understanding is the same technology used in the Oxycontin abuse-deterrent formulation will be the one used in Purdue's formulation for hydrocodone. While I do agree accidental chewing is a worthy problem to eliminate, I'm not sure the agency could be more clear on its position.

     

    I'm doing a project in general regarding the full market potential for any ER acetaminophen free hydrocodone, if anyone wants to join me check it out here:
    http://bit.ly/1lRc4Lk
    8 Jul 2014, 12:04 PM Reply Like
  • PharmSterZzZ
    , contributor
    Comments (253) | Send Message
     
    (Reuters) - U.S. Food and Drug Administration Commissioner Margaret Hamburg on Thursday defended the agency's approval of Zogenix Inc's Zohydro, saying the powerful prescription opioid offered a "unique" option to help treat pain.

     

    Hamburg, responding to a query from a U.S. lawmaker, said that currently approved hydrocodone drugs also contain acetaminophen, which can be toxic to the liver at higher doses. Zohydro does not contain the added pain ingredient.

     

    "We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy," Hamburg said at a hearing of the Senate's Health, Education, Labor and Pensions Committee.
    1 Aug 2014, 04:42 PM Reply Like
  • Jbgoose
    , contributor
    Comments (3259) | Send Message
     
    Joe/ I like your project, look forward to seeing what your doctor experts have to say. Hopefully you get a few pharmacists on the panel.

     

    Some questions: How do you plan on managing cost sensitive patients? How do plan on managing proper dosing given ART medications have thus far proven less effective in practice? Given many overdose situations are because patients forget if they took a pill or not, how do you currently manage this? Protect yourself from lawsuits?

     

    Looks fantastic . JBG
    8 Jul 2014, 02:04 PM Reply Like
  • pj4272
    , contributor
    Comments (28) | Send Message
     
    Court victory for $ZGNX just posted

     

    http://bit.ly/1jbU43F
    8 Jul 2014, 02:37 PM Reply Like
  • TGilbert
    , contributor
    Comments (24) | Send Message
     
    They've been so vocal in support of their decision likely because of the dangerous precedent that is being set when Congress can try and challenge said decision. Of course this on top of the fact that all the complaints against the drug are either false, overstated, or missing crucial context.
    8 Jul 2014, 02:55 PM Reply Like
  • Jbgoose
    , contributor
    Comments (3259) | Send Message
     
    So what is all doing with their stock? Do all feel this is a day traders dream or nightmare?
    9 Jul 2014, 09:57 AM Reply Like
  • followsgartman
    , contributor
    Comments (22) | Send Message
     
    Again, another bunch of comments that bring into question how the majority of the respondents arrived at their conclusions and their overall decision making skill-set specific to the stock market. When I first started in the industry, I learned that 3 - 5 year so-called veterans were often making the investment decisions for some investment funds. Moreover, I see this as a reality with respect to this particular investment and some of the comments that are made. I feel sorry for those persons that really have no clue how the market operates and create a wild set of assumptions that do not exist in reality. They often believe these assumptions to be true, because they are sometime validated by an unrelated event that causes the market to move, thus, the self-fulfilling prophecy validation and life go on, I am flabbergasted at what I sometimes read on these boards. It is odd, but it is a source of amusement. For those who want to look at the market from a new and better perspective, then, you might consider ignoring ninety-nine percent of what you read in the comments, and put some real critical thinking into your decision making process. Nevertheless, wild stuff, and they often contain entertainment value if nothing else.

     

    Now let us get real and discard the hyperbole with respect to this particular situation. Zogenix is a Penney stock and the company is going to need to replenish its capital at year-end. No one can predict the future in respect to the FDA’s response to their October NDA, will there be sufficient safety characteristics built into their initial deterrence technology? From my perception, I anticipate opioid’s have about a two-four year relevancy, because the backlash and negative costs surrounding opioids are significant. I understand they failed to fill fourteen sales positions, and they dropped two additional underperforming territories. The rumor is approximately fifty sales positions will be cut, and I see this as a positive rather than a negative, especially significant when compared to how management wasted investor’s capital in the past associated to “Sumavel Dose Pro” (a niche, within a niche market product). The company and the bulls appear to find themselves caught up in the hype, unable to see the forest through the trees based on cognitive dissidence.

     

    However, the fact remains in the world of opioids this is one of many “go-to” options and likely the most dangerous option of the bunch that are already approved. It is expensive, its risks outweigh its benefits, and even the carefully crafted results in trials are unimpressive, when a placebo can essentially compete with the drug on many levels. I am unconvinced. The only thing Zogenix has going for them is that many significant investors are stuck and they are reluctant to dump, which would collapse the share price to about $1.00. Thus, the large investors are sticking around impatiently waiting for a window of opportunity to open where some will jump ship. Moreover, a stock like this really affects the books, which is not at all desirable.

     

    My belief is the safer way to play this stock like an option, there will be excellent opportunities to capitalize on its dips and swings. The company is nothing more than a small-cap irrelevant stock in a huge market reserved for the tried, proven, and tested. It has a very small chance to become relevant with other “bigger and better” players’ entering the market against the backlash that surrounds opioids that will not disappear anytime soon. You have to recognize, without discarding the fact that the United States represents almost ninety-five percent of the entire opioid market, thus, you have to ask yourself how do pain patients in other parts of the world survive without free unfettered access to opioids?

     

    This is an unacceptable reality, the negative effects surrounding opioid misuse (and in this category I could provide pages and pages of negatives) are also negatively affecting our deficit and ultimately our economic survival. Look at the situation rationally, and you will not be placing yourself in a high-risk situation with minimal opportunity for meaningful gains in share price over the medium or long-term.
    9 Jul 2014, 05:02 PM Reply Like
  • jdadyfinance
    , contributor
    Comments (238) | Send Message
     
    Ummm it's spelled penny and the fact remains the drug meets an unmet need.
    9 Jul 2014, 11:28 PM Reply Like
  • Jbgoose
    , contributor
    Comments (3259) | Send Message
     
    Followsgartman/ you covered much ground. Of course this is a spec play. Of course comments are entertaining for most here, though many provide solid statements to research on your own. The opioid debate is decades old. You know the story and seem to agree with the hysteria side (my words). How is a firm like ACUR, which I will never touch again after selling it in time, any more ethical? They use scare tactics to (not sell) Nexafed. No need to answer... They are roast beef. Sold them in time as well.

     

    I agree with your overall thesis even if I do find it unfortunate and rigged, unfair. Zohydro fills the needs for millions of patients already going through hurdles and avoids Liver damage, a health crises itself. Always two sides. Purdue, who started the Oxy epidemic, wins again. And so you are correct, the information about sales force problems is an example of a comment one can look into. And yes, many fund managers employ younger teams to help decide some investments. For the managers are at dinners, conferences and numerous industry meetings to sell themselves and their fund firm. That is the job. I have experience with this from 1998 on when hosting due diligence conferences. I am ethical. This part of the business is not wrong in practice. Not all funds work this way, but many do. Where the line is gray.... Some also run hedge funds on the side strikingly similar to the mutual fund. Old news for industry folks but unknown to many on Seeking Alpha. Imagine that, being allowed to run a public fund and a hedge on the side with the same research but different methods where one can position against other managers in the firm or even their own fund. That was in the news cycle for about a minute. Missed by all outside the industry.

     

    The most ironic thing for ZGNX is Hydrocodone cannot be abused in the same manners as oxycodone; it breaks down differently in the body. I will leave details up to those experts. So the ART, stated as unproven by the FDA, except for Purdue, doesn't matter in the end. The vast majority of 'abuse' is simply people taking more pills than prescribed, orally. Then those with poly abuse issues are the 2nd category (mixing with alcohol per example, causing liver damage). The percentage who snort, inhale or shoot it is minimal.

     

    Unfortunately most in the top categories 'abuse' because they are in a lot of pain, many forget when the last dose was taken given the 7+ other drugs they must take on average. And doctors are 'frightened' to prescribe the correct ER pain medications that would help avoid the need for any patient to take more than is prescribed. If docs could correctly work with the patients this situation would change immediately. It's a horrible cycle. The percentage who abuse will be the same no matter what. The over availability of drugs of abuse is a real issue. So is the overall drug war failure. Thus, legal medicinal and recreational cannabis will continue, never looking back. This takes money away from the bad guys and gives back to the USA. Cash money is cash money.

     

    My motive for stating some of this public is I am a believer in patient rights, am disgusted by the politics and close minded people using this particular issue for personal reasons. It hurts patients in the end, what happened at the charged FDA meetings is wrong. They killed off a company with good intentions and a well known, already generic and well profiled medicine. Why? For political theater.

     

    For folks still in/ a total gamble. For traders, there looks to be roller coaster pricing ahead with the many triggering events and media headlines in play.

     

    FollowsGartman is correct, I feel, regarding his ideas how to play this like an option. I will add, camp. also use it for tax loss purposes, perhaps average down so the loss doesn't feel so bad. And learn from it.

     

    The patient still wins as long as affordable medicines remain available ... The patient should never have to fight in this way. It is against all morality, ethical medicine practice and the result is a heroin epidemic. Shame.
    10 Jul 2014, 11:36 AM Reply Like
  • followsgartman
    , contributor
    Comments (22) | Send Message
     
    I am very impressed with your observations, which I think expanded upon mine. Additionally, I like your writing style. I think you explained your thoughts with clarity, and in a side-by-side comparison, your comments are easier to understand than mine. In contrast, I entered the business a few years before you; launching my business from motivational influences gleaned from Arthur B. Laffer in a private multi-day conference. At that time, Dr. Laffer’s hair was not the jet black that it is today, (at least it was when I last saw him). Moreover, Dr. Laffer was President Reagan’s economic advisor, and the Dow was hovering around 800. Since then I have participated in some incredible activities associated with and around the equity and financial markets.

     

    However, I am still a rookie and student of the markets compared to some, recognizing that I still have much to learn in many respects. Sadly, I may have blown a fuse, as my passion for the markets is less than it was last year, and less than it was the year before. I have a few more arrows in my quill than some. I can look back at the genius of software programs like “Structure,” and contrast the technology of yesteryear to today’s technology. Moreover, after thirty years of market education, I think there comes a point in this context where one can see critical things in the market that others are unable to see, because they have not lived the experience, but that is probably where it stops in my world.

     

    I was encouraged by your comments and that you operate your business in an ethically responsible manner. I believe this is not the norm today in many respects, but this also contributes to a long career versus a shorter one for others who may be willing to go to the dark side, thus, their business and book is intertwined with conflict.

     

    Thank-you very much for providing others with what I perceive to be extremely valuable commentary by way of your response.
    10 Jul 2014, 05:39 PM Reply Like
  • Jbgoose
    , contributor
    Comments (3259) | Send Message
     
    Followsgartman/ Thank you for your contributions and above words, as well. JBG
    11 Jul 2014, 09:49 AM Reply Like
  • 11137741
    , contributor
    Comments (240) | Send Message
     
    They over think the abuse deterant, of course... Some way to create a higher cost, I guess... I use to do these pills here in South FLorida. Got caught up in it for a few months after knee surgery in 2005. At the time you could get anything cheap. I here the steets are loaded now with Heroin (big time)... Pills are now small time. Goes to show, they are never up with the times. Afganistan gets so much USA money - one way or another. Send them billions free, terrorist steal it, use that to grow more poppy, then send it back here to kill us...

     

    USA is so dumb.. Anyway, there was one with a coating, just straped it off before crushing it. Then another one that turned to Mush when trying to snort it. That was the best deterant.... Another one, you don't see it to make the pills bigger and mixed with DE or another safe filler substance so even if you crush and snort it, the effect would be minimal unless you packed your sinuses... No one would do that...

     

    Anyway you cut it, a USER will find a way to get the rush. Deterants do stop young kids from O.D.s... Usually they are new. Old days had kids that never took anything and would take an 80 mg oxycotin because it looked so harmless....
    11 Jul 2014, 11:32 AM Reply Like
  • Jbgoose
    , contributor
    Comments (3259) | Send Message
     
    11137741/ glad you made it. It is laughable how we not only have the longest war with the largest grower of poppies, then support them further by guarding the fields which end up supplying those hooked with no script just to 'feel better' and not even get 'high'. The filler like talc is enough for most to not snort it, the filler that turns it soggy works better but is defeated via a microwave. Like you said - a true addict will always find a way no matter what anyone says or any ART technology ever made. The irony. Statistically the numbers of addicts are about the same as always overall. When looking at past statistics the percentage of users vs abusers vs patients remains rather steady over the decades. Percentage wise the heroin is up triple digits and the pills way down. The quality of the heroin is higher than ever. One would think a smart country would figure it out. Even the Brits did, and you can buy codeine on the shelf with no regs in most countries, where there is a known and controlled population of users who can seek treatment at will, when they are ready and it has a better chance to work. I don't know why the USA can't figure it out. Oh, other than the financial aspects to just two main industries, jailers and pharma. Plus the local police who seize assets and make a bundle. It is the truth unfortunately. JBG (now is when all the political minded folks come to play)
    12 Jul 2014, 03:28 PM Reply Like
  • Jbgoose
    , contributor
    Comments (3259) | Send Message
     
    I spoke to a doctor yesterday, specifically asking about Zohydro. This doc is familiar with the pain specialty, unique insights obtained from having been active in The Suboxone program, until they made changes that chased away the most productive doctors who wanted to make a difference.

     

    Paraphrasing below:

     

    Dr. said 'None of the current opioid products, brand nor generic, work as claimed. None of them act as long as advertised. It is a problem because my name will end up on the reports analyzed by people with no medical training to understand this issue. Generic medications are the way we will continue to prescribe this class of medicines'

     

    The group of of peers from the Suboxone program that also stopped participating do agree; 'it was the biggest professional mistake made with (our) practice, wasted all of my time' - The fact is more than a few patients assigned ended up an OD and at least 2 died, long time heroin addicts with poly abuse issues. ALL POLY ABUsE... That hurts as they thought this was all going to help... Anyhow, they stopped writing as many pain Meds - limiting what was wrote, other than hydrocodone or codeine (Tylenol 3), for patients who it was clearly advantageous for. The Brands are literally laughed at due to cost and the many other generic medications in the arsenal responsibly used for real patients. Only the most obvious cases will be prescribed anything stronger than Hydro, and all are vetted accordingly.
    2 Aug 2014, 11:29 AM Reply Like
  • Joe McCann
    , contributor
    Comments (261) | Send Message
     
    JBGoose -

     

    The view that generics satisfy the vast majority of pain patients needs was the thesis of my last ZGNX article. I honestly went into those calls anticipating hearing something like "sure 5-10% of my patients could reasonably be put on this", but that wasn't the case. I've been roundly criticized on by many longs who generally seem a bit emotional about things, but the launch isn't going well and the cash position is a bit misleading given the cost structure the company has decided to go with in my opinion.

     

    I'd have to think that the CCO departing 4-5 months into the launch endorses the view that the launch isn't going well. Maybe we'll get a change to the cost structure and general direction on the next call.

     

    Personally, I think the company would do well to sell the rights of Zohydro to an established pain player - get a royalty on it and eliminate all costs and distraction from the drug. Then they can focus on Relday, which after Phase I positive data I would think is a relatively low risk program.

     

    I'll post more on that thought in a blog post tomorrow.
    3 Aug 2014, 03:08 PM Reply Like
  • Jbgoose
    , contributor
    Comments (3259) | Send Message
     
    Joe/ now that you remind me about it I do recall your article, and projects. Selling the rights as you mention above is one valid course of action. No idea what they would sell for, how to value, and we can't change the politics that crushed them vs Purdue and Mylan.

     

    If ZGNX had not been targeted, maliciously coordinated against via parties with financial gain involved - what would have the sales been? More than 5-10%. I think this can be proven in court, argued well enough for a rather large settlement- if ZGNX can afford the case. Which they can't?? The emotions are hard to ignore here, given the impact on lives. I'm better removing them from investing decisions these days vs a few years back esp with pharma. Like a WFM fan, too many are emotionally bound and might lose a boatload rather than trade smart, the lack of organic meats is one material fact that shows how the infrastructure of farming is changing but this is ignored. Got to run..
    4 Aug 2014, 11:02 AM Reply Like
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