The level of attention garnered by Zohydro ER, the first FDA-approved single-entity (not combined with an analgesic) and extended-release hydrocodone product, and the efforts to overturn that approval, is perhaps unprecedented. As we previously reported, many state and federal officials have pushed FDA to revoke the drug's approval, and Governor Deval Patrick banned the drug outright in Massachusetts. Zogenix Inc., the maker of Zohydro responded by filing suit, and succeeded in getting a Federal Court to overturn the ban, on the basis that it is preempted by FDA's approval of the drug. Vermont and Rhode Island have also enacted measures related to Zohydro and opioid abuse generally.
FDA continues to stand behind the approval, noting that it is an important option to treat drug addiction. On a related note, FDA recently approved a hand-held injector intended for emergency treatment in cases of opioid overdose and announced updated safety measures for extended-release and long-acting opioids. Additionally, last week, Commissioner Margaret Hamburg issued a statement on prescription opioid abuse and FDA established a docket to receive suggestions and public comments on methods to deter abuse of combination opioid analgesic products, as a part of a multi-pronged approach to addressing painkiller abuse.
Matthew R. Bowles assisted in the preparation of this Update.
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