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Zogenix, Zohydro ER Face Familiar Post-Approval Hurdles

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Developmental biotechnology company Zogenix (NASDAQ: ZGNX  ) has had a surprisingly successful regulatory run with its single-ingredient hydrocodone painkiller candidate, Zohydro ER. Earlier this year, against an 11-2 vote by an advisory panel opposed to its significant abuse potential, the Food and Drug Administration approved Zohydro for treatment of uncontrolled pain.

The approval of the product has brought about significant criticism from law enforcement and medical practitioner alike – Zohydro would be the first ever hydrocodone product on the US domestic market not combined with a dose-limiting second ingredient. Furthermore, Zohydro capsules are not formulated in a way that prevents their abuse when opened, broken, or dissolved.  

In a nod to its potential danger, Zohydro is subject to the FDA's Risk Evaluation and Mitigation Stategies program for long acting morphine-based painkillers. This program requires close monitoring of Zohydro use and prescribing among other strict controls; Zogenix has further agreed to conduct a number of post-marketing studies further weigh in on Zohydro's safety. 

However, that may not be enough for many critics. In a recent letter to the FDA, 28 state attorneys general demanded the FDA reconsider their approval of the painkiller citing skyrocketing prescription abuse trends and Zohydro's uniquely high abuse potential. A move on the part of the FDA should be a signal to investors of big moves in Zogenix stock price ahead. 

A new breed of painkiller
Zohydro is certainly not the first pain medication to come under close scrutiny. Brand name Vicodin, made by AbbVie (NYSE: ABBV  ) , along with generic hydrocodone/acetaminophen combinations, produced by generic drug manufacturers including Actavis (NYSE: AGN  ) and Endo Health Solutions (NASDAQ: ENDP  ) , are widely distributed.

More than 130 million U.S. hydrocodone-containing prescriptions are written annually, which are subject to numerous state and federal prescription drug monitoring programs designed to identify worrying trends that may indicate diversion or improper prescribing. 

However, the greater concern is not necessarily with another painkiller joining the market. While hydrocodone-contain medications are already consistently the most highly prescribed medications year over year, the greater worries are rooted in how Zohydro capsules are made.

Presently available hydrocodone products usually contain a second ingredient that makes it difficult for prescribers and patients to overuse -- a feature that pure hydrocodone Zohydro capsules do not include. Even more worrying, Zohydro capsules are not chemically designed to stop abusers from getting a stronger-than-intended effect from the normally long acting medication.

Popular Purdue Pharmaceutical painkiller Oxycontin famously came a hair's distance from becoming banned before Purdue agreed to fund extensive drug monitoring programs in addition to reformulating the product to defeat attempts to abuse it. New generation Oxycontin tablets are difficult to crush and resist dissolution among other chemical safeguards. Early in 2013, the FDA made a final move to formally ban the original formulation from the market. 

Zogenix's next plays
Zohydro's trajectory may very well mirror that of Oxycontin over the next few months. As an alternative to outright rollback of Zohydro's approval, state attorneys hailing from major painkiller markets like Texas and Florida have strongly recommended that the FDA hold Zogenix to a "rigorous" timeframe in which Zohydro must be reformulated to reduce its risk potential. 

Fortunately, Zogenix has already contracted a third party, Altus Formulation, to assist its team with a redesign of the Zohydro capsule and capsule ingredients that could potentially satisfy critics. That being said, this new relationship does not prevent the FDA from reconsidering Zohydro's appropriateness for market and certainly does not prevent its critics from raising distribution hurdles within state boundaries. 

A recall of Zohydro's approval would at least temporarily sink Zogenix's flagship product, and stricter controls or outright bans within individual states could seriously hamper its marketability. Zogenix will need to play its newest set of obstacles wisely if its wants to ensure patient safety and Zohydro's success.

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Read/Post Comments (9) | Recommend This Article (2)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On December 31, 2013, at 5:36 PM, daveoster wrote:

    Really? Does The "Fool" ever get tired of dogging Zogenix? And what is the point anyhow? Pure Hydrocodone has a very specific market place which is actually not that huge. There are many patients which can and will benefit from a weaker and safer opioid drug. The FDA is NOT going to reconsider their approval because 28 or 50 state AG's send a letter asking them to. Besides, the letter also suggested the FDA help Zogenix fast track an AD formula. The FDA is not going to spend over a year considering an NDA, completing a complicated REMS, and approving Zohydro just to turn around and pull it because of political pressure. The FDA had to have known that was coming anyhow. Do you think they were surprised by the backlash? No of course not. The AG's did their "job" and wrote the letter and now they can go back to sleep and suck tax payer funds.

    Now about abuse. Oh for goodness sakes, stop with that cruse already. Tobacco, alcohol, and fried chicken are killing WAY more people than Zohydro EVER will! If someone wants to sit on their butt and down 4,000 calories and ruin their life and health, well so be it. Some people are junkies and that is the way it goes. Do not punish the majority to protect a few idiots!

  • Report this Comment On December 31, 2013, at 9:10 PM, bamobrien wrote:

    Some good points but I think you're discounting how epidemic prescription drug abuse is becoming and how earnest attempts the attempts are to combat it. Prescription medication abuse is rapidly outpacing illegal drug abuse and claims tens of thousands of lives yearly. There's a reason why Oxycontin's reformulation was a multimillion dollar effort, why big box retail pharmacy chains are beginning to blacklist bad actor prescribers, why the FDA's own advisory panel overwhelming opposed Zohydro, why Congress and the FDA has both proposed to reschedule *combination* hydrocodone and any number of other events that part of a trend influenced by the increasing danger of opioid abuse and the awareness of that danger.

    Sure the FDA may or may not reconsider its approval, but the door is absolutely open. Again I want to reiterate that state agencies could easily put additional pressures on Zohydro and Zogenix as well if the FDA does not act just as states have individually implemented monitoring and registration programs against Vicodin or rescheduling efforts against tramadol.

    Just because tobacco, alcohol, and other lifestyle vices are making greater contribution to mortality hardly means we shouldn't make an effort to address other problems. Your pet long doesn't change any of that.

  • Report this Comment On January 01, 2014, at 3:32 PM, p716 wrote:

    The reason these drugs are so scrutinized is the illegal past activities of Purdue and the horror their marketing tactics brought out. These meds are needed but by a select group of pain specialists. They should be the only ones to prescribe these and they should be regulated by a prior authorization. The company should also be limited in the scope of their promotion.

  • Report this Comment On January 01, 2014, at 5:16 PM, efr wrote:

    Why is there no mention of it's schedule class vs todays widely prescribed hydrocone? Why is there no mention that this cannot be prescribed to people on an 'an needed' basis, but the patient must be a long term/constant pain patient? Why is there no mention on the positive results for those patients? Why is there not more mention of the positive removal of acetaminophen, and what that drugs negative effects to a patients health are. Is this all too irrelevant, or just prevented too much from the authors point that he wanted put forth?

  • Report this Comment On January 01, 2014, at 8:36 PM, papete wrote:

    The Fool must love to spin the wheel on this topic--and get no traction. The facts will not change. There are people with chronic pain. Physicians are obligated to manage that pain; and if conservative treatment fails, narcotic pain medication is available. If people choose to abuse MEDICATION, pulling Zyhydro ER will do nothing to stop that behavior. Why? Because there is Morphine, Opana, Dilaudid, Fentora, and Oxycontin (no matter what formulation) for all the abusing pleasure you could ever want.

  • Report this Comment On January 01, 2014, at 11:30 PM, bamobrien wrote:

    The comparison of schedules is irrelevant given the FDA has already moved to lobby the DEA to reschedule combination products.

    An indication for scheduled pain does NOT prevent off-label prescribing for as-needed dosing.

    Positive results for Zohydro can be replicated with other pain medications and I never made any attempt to say Zohydro was not effective. That being said you should probably recognize that Zohydro's clinical trials never pit Zohydro against any other pain medications but rather only against placebo (i.e. sugar pills)- not a very strong argument.

    Removal of acetaminophen is only positive for the smallest sliver of hepatically compromised patients. Acetaminophen and hydrocodone synergistic effects are actually a new area of study- there's evidence removing acetaminophen actually forces higher doses of hydrocodone equivalents.

    Try again, efr. I don't think anything in the article is indefensible or biased.

    To papete's point: the medications you mentioned are indeed abused BUT many are formulated to defeat abuse. Zohydro is not.

  • Report this Comment On January 02, 2014, at 8:17 AM, petemyers2012 wrote:

    This is such nonsense it is not even worth commenting. Easily the worst article I have read in a long time.

  • Report this Comment On January 02, 2014, at 10:17 AM, amylinaire wrote:

    Criticism against Zohydro is being is wrongly focused. It is being waged as Zohydro will be a significant contributor to grow new drug abuse because its hydrocodone is pure and it is not tamper resistant.

    The problem with this argument is that other hydrocodone products currently on the market are currently classified as Class 3 drugs, they are widely available and do get prescribed upon request as needed. The cries to ban Zohydro without cries for removal of the other hydrocodone products simply demonstrates an un-level field that big pharma wants to keep and maintain their existing profits.

    Before the FDA approved Zohydro, the FDA recognized the hydrocodone drug abuse availability problem and is properly addressing the abuse issue by planning to move all the opioid drugs currently available as Class 3 to Class 2 which tightens/restricts prescriptions.

    What is being lost in this misdirected focus against Zohydro is the legitimate population (mostly elderly) suffering from chronic pain. Hydrocodone is the weakest opioid drug. Attempts to make a tamper resistant version of hydrocodone have thus far resulted in an altered delivery effectiveness profile for use as a pain medication. Chronic pain users need to reduce their acetaminophen intake to prevent liver damage. A damaged liver to legitimate chronic pain patients causes unneeded additional suffering in addition to their unbearable pain usually requiring a liver transplant or death. Zohydro offers true benefits to chronic pain patients by eliminating the acetaminophen, extending the pain relief profile to a longer period (12 hrs) and provides a new option in the toolbox to treat chronic pain.

    Because hydrocodone is the weakest opioid, it will become the gateway drug used to treat chronic pain before moving to the more powerful opioid drugs.

    Zohydro was never planned or approved for Class 3 distribution. If you follow the money, the other big pharma opioid drug suppliers are the only ones to benefit from a proposed Zohydro’s removal/withdrawal. They don’t want their profits impacted and are instigating hurdles for Zohydro and taking advantage of good people fighting the drug abuse war for their benefit.

    The FDA should maintain a level playing field for the drug review and approval process. There are multiple facets to the drug abuse problem. By moving all opioid drugs to a Class 2 schedule is the right thing for the FDA to do. Politicians are now being used by Zohydro competitors to attempt to maintain their profits. These cries by politicians against Zohydro ignore the benefit to the larger legitimate chronic pain users.

  • Report this Comment On January 15, 2014, at 5:37 PM, PainCrusader wrote:

    I have been a chronic pain management patient it is a joke how all of the sudden they are creating a problem where there really isnt one, go back to 2008 and Drs would gladly write 180 80mg Oycontin and 120 30 Mg Roxicodone(Oxycodone) getting any form of Hydrocodone however was not that big a deal since it is cut with either tylenlol, ibuprofen, etc. There is no pure hyrdocodone product on the market like there is for oxycodone. Whether its schedule 2 or 3, these pharmacies will give legit patients a hard time even filling this Zogenix when and if it does ever hit the market. Dr Drew even states that taking opiates in a regular manner as prescribed are of great benefit and have little to no side effects. Tylenol aka acetminophen however has numerous side effects including liver issues. Whether it get approved or not if its schedule 2, Pharmcies will lie and claim they dont have it or its on back order. Chronic Pain Patients need rights I am sick and tired of this crusade against people including myself not being allowed to take pain medication and get it from the pharmacy in a timely fashion.

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