Zogenix Inc, the company that manufactures the recently approved Zohydro ER, a single-entity extended-release (ER) hydrocodone, has filed a lawsuit in the US District Court in Massachusetts, requesting a temporary restraining order against execution of an executive order by that state's governor banning prescription and dispensing of its product.
On March 27, Massachusetts Governor Deval Patrick declared a public health emergency in response to the growing opioid addiction epidemic. Among these measures, he directed the state's Department of Public Health (DPH) to prohibit the prescribing and dispensing of any hydrocodone-only formulation until adequate measures are in place to protect against potential diversion and overdose.
The Zogenix lawsuit argues that this move is "in direct conflict with the authority of the FDA (Food and Drug Administration) to determine on behalf of the public whether a drug is safe and effective, and to impose the measures necessary to ensure that the drug will be used safely and appropriately," the company states in a press release."The legal action comes after a formal written request to the Governor for a meeting to discuss the facts about the product went unanswered."
After "very limited interactions with his staff after the decision," Zogenix is "convinced that the decision was driven by factual inaccuracies about the science and the data," the release notes.
"Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order," said Roger Hawley, Zogenix chief executive officer.
The FDA approved Zohydro ER last October "after an exhaustive 18-month review of the clinical trial data," said Hawley. "The rigorous FDA review process serves the nation's public health needs, the medical community and those in severe chronic pain, and the FDA regulatory authority simply should not be usurped by individual states."
Zohydro ER is the first and only ER hydrocodone without acetaminophen for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
"For those patients in Massachusetts struggling every day with severe chronic pain who are tolerating immediate-release hydrocodone therapies, which contain acetaminophen, having a new option of hydrocodone could provide a significant benefit at the same daily dose currently being prescribed and taken 4-6 times per day and reduce their risk of overdose of acetaminophen," the Zogenix release concludes.
Zohydro ER is the only hydrocodone product on the market subject to a risk evaluation and mitigation strategy specifically developed by the FDA to minimize the risk for abuse of long-acting opioid drugs, and is the only hydrocodone product currently subject to Schedule II controls by the Drug Enforcement Administration, the company points out. "These requirements make Zohydro ER the most comprehensively regulated hydrocodone product on the market today, with more safeguards against misuse, abuse and diversion than any other hydrocodone-based product."
The suit is the latest development in a saga that began when the FDA approved Zohydro ER, which doesn't have abuse-deterrent technology, even though its own advisory panel recommended against approving the drug in an 11 to 2 vote.
The approval was also considered somewhat strange by some in light of the FDA's announced strategies to tackle the growing problem of opioid abuse. One such strategy is to introduce opioids with abuse-deterrent properties.
Last fall, the FDA announced stricter labeling on ER/long-acting opioids and plans to change the scheduling for hydrocodone combination medications such as Vicodin (a combination of hydrocodone and acetaminophen) from Schedule III to Schedule II to increase security measures.
Since then, the approval of Zohydro ER sparked a call for its reversal by 29 state attorneys general and a coalition of groups calling itself "FedUp!: A Coalition to End the Opioid Epidemic." Bills have been introduced in both the House and the Senate to overturn approval of this drug.
In Vermont, Governor Peter Shumlin is reportedly also introducing restrictions on prescribing Zohydro ER, although not an outright ban.
Zogenix has since announced it has entered into an agreement to develop abuse-deterrent formulations of Zohydro ER.
Massachusetts is facing "an epidemic of opiate abuse" that should be treated as "a public health crisis," said Governor Patrick. Use of oxycodone and other narcotic painkillers in the state has been rising for the last few years. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90%.
According to a statement released by his office,Governor Patrick directed the DPH to take steps "to combat overdoses, stop the epidemic from getting worse, help those already addicted to recover and map a long-term solution to ending widespread opiate abuse in the Commonwealth." The declaration grants emergency powers to DPH Commissioner Cheryl Bartlett, RN, who will work with the Public Health Council to take several steps, including the ban on hydrocodone-only drugs.
Other companies are moving ahead with their abuse-deterrent products. Last month, Purdue Pharma LP announced topline results showing its ER, single-entity, abuse-deterrent formulation (hydrocodone bitartrate) significantly reduces back pain compared with placebo.
The agent appears to be the first ER hydrocodone product with abuse-deterrent properties headed for market. Although the formulation is not totally abuse-proof, it contains a polymer that makes it difficult to crush; it becomes gummy, which prevents it from being easily snorted or drawn into a syringe to inject.
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Cite this: Zogenix Files Suit Against State Ban on Zohydro ER - Medscape - Apr 09, 2014.