FDA approves abuse-deterrent Hysingla ER
FDA has approved Purdue Pharma's hydrocodone drug Hysingla ER making it the first and only hydrocodone product with abuse-deterrent properties. Armed with the deterrent advantage, the once-a-day extended release opioid analgesic will go head-to-head commercially with Zogenix's Zohydro, a twice-a-day hydrocodone. The agency's approval of Zohydro last year spurred protests from public health advocates concerned it would lead to the same abuses seen with the oxycodone OxyContin, before the drug was reformulated to deter abuse.
Hysingla ER is expected to deter misuse through chewing, snorting and injection, though abuse by intravenous, intranasal, and oral routes is still possible. Approved for treating pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, Hysingla ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) requiring companies to provide safe prescribing programs to professionals, Medication Guides and patient counseling documents.
The FDA is also requiring post marketing studies to assess the effects of the drug's abuse-deterrent features.