We are quickly coming up on the one year anniversary of the FDA approval of Zohydro ER® (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate (FDA News Release October 2013).
In leading up to this announcement by the FDA, Zohydro ER® was heralded as the first extended-release Hydrocodone product which was also acetaminophen-free, thereby reducing the risk for overdoses caused by acute acetaminophen toxicity. (Zogenix press release 2013). In a normal person, 4 grams (4000mg) of acetaminophen is the recommended maximum dose, while in someone with liver dysfunction, 2 grams (2000mg) is the recommended maximum dosage. Before the combination products of acetaminophen were reformulated to contain no more than 325mg per dose, all one needed to do was to take 6 tablets per day of Vicodin ES (7.5/750mg) and be at the 4 gram maximum of acetaminophen. As some statistics state that close to 70% of all unintentional overdoses are caused by hydrocodone in combination with acetaminophen, Zohydro ER® is designed to allow for around-the-clock pain coverage without the fear of acetaminophen toxicity and liver dysfunction.
Shortly thereafter, petitions began to find their way to the FDA with the hopes of denying the approval and release of Zohydro ER®. Of note, Zohydro ER® was approved even though the FDA advisory panel voted 12 -2 against its release. Critics argued that Zohydro ER® would become the next OxyContin®, allowing for widespread abuse and diversion with its use. Zohydro ER® was released without a tamper-resistant formulation, which both OxyContin® and Opana ER® currently have. Zohydro ER® is formulated with a spheroidal oral drug absorption system, also known as SODAS®, which is currently formulated in medications such as Ritalin LA® and Avinza® (Morphine Sulfate ER). This technology allows for a customized dosage form, which responds directly to the individual needs of the patient. The critics also argued that this type of formulation would increase the incidence of both diversion and abuse.
Due to the epidemic already present in the United States with both opioid consumption and abuse, the Attorneys General from twenty-eight states and four US Senators tried to take legal action against Zogenix, Inc., the makers of Zohydro ER®, and the FDA. The State of Massachusetts enacted a “ban” of the sale of this medication to patients. The Governor of Massachusetts, Duvall Patrick, cited a “public health emergency secondary to opioid abuse” as the reason for this action. The State of Vermont also took action to make prescribing Zohydro ER® very difficult for prescribers. Shortly after this, Zogenix filed a motion in US District Court against the State of Massachusetts arguing that the “ban” put into place was unconstitutional. In July of this year, Judge Rya Zobel ruled in favor of Zogenix and thereby reversed the ban put into place by Massachusetts, citing ambiguity in the proposed ban by the Governor.
As we approach the one year anniversary of the release of Zohydro ER®, we will be better able to assess if what the critics have argued all along is true. Or, is the real issue the disease of addiction? Zohydro ER® is already finding its way onto claims payment histories and does come with a hefty price tag. Once we examine the data, then we will better understand which road Zohydro ER® will take us down.
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