The FDA announced Friday that it approved Zogenix' Zohydro ER (hydrocodone bitartrate) to manage severe pain that requires daily, continuous, long-term treatment and for which alternative therapies are inadequate. The regulator noted that the long-acting (LA) opioid analgesic is the first extended-release (ER), single-entity, hydrocodone-containing drug product cleared for use in the US. Zogenix shares climbed as much as 40 percent on the news.
Labelling for the Schedule II drug conforms to updated labelling requirements for all ER/LA opioid analgesics announced by the FDA in September, the agency said. The update followed a July report by the US Centers for Disease Control and Prevention, which found that fatal overdoses from prescription pain drugs increased several-fold among men and women between 1999 and 2010. The agency noted that Zohydro ER is the first opioid to be labelled in this manner, which is "expected to improve the safety of all such medicines by encouraging more appropriate prescribing [and] patient monitoring."
An FDA advisory panel in December 2012 had voted 11-2 against recommending the drug for approval, citing concerns about the danger of addiction posed by opioids. However, the regulator noted that Zohydro ER's safety is based on clinical studies of more than 1100 people with chronic pain, while efficacy data based on a clinical trial of over 500 patients with chronic low back pain demonstrated significant improvement in chronic pain versus placebo. The FDA said it is requiring postmarketing studies of the drug, which will also be required for other ER/LA opioid analgesics, "to assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with long-term use beyond 12 weeks."
In January, an FDA panel voted 19-10 to recommend moving drugs containing hydrocodone from Schedule III to Schedule II, and the agency recently announced plans to recommend to the Department of Health and Human Services that such drugs should be reclassified into the more restrictive Schedule II category. The regulator plans to formally make the recommendation by early December, and Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, suggested the new rules could take effect as soon as next year.
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