The benefits of oxymorphone hydrochloride extended-release tablets (Opana ER, Endo Pharmaceuticals) do not outweigh its risks to public health, according to a joint FDA advisory committee.
Members of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a two-day meeting and voted 18-8—with one abstention—that the drug’s risk–benefit ratio has changed for the worst. Most of the panelists agreed that the drug should be removed from the market due to its high potential for IV abuse and misuse: Several outbreaks of HIV, hepatitis C and vascular issues were related to IV abuse of the drug.
“This formulation of oxymorphone has unintended consequences that deserve its removal from market,” said Charles Emala, MD, professor of anesthesiology at Columbia University in New York City, one of the panelists who voted against the drug, MedPage Today reported.
Endo presented efficacy data during the meeting, including postmarketing data on abuse and misuse compiled from the National Addictions Vigilance Intervention and Prevention Program and the RADARS System Drug Diversion Program. The company reported that the increases in oxymorphone-related death and overdose rates were associated with the introduction of the abuse-deterrent formulation of oxycodone (OxyContin ADF; Purdue Pharma) in August 2010, and decreased after the introduction of the oxymorphone reformulation.
Many panelists acknowledged a lack of data, but believed there was enough to conclude that oxymorphone carried increased risks related to injection abuse.
The drug has had a difficult regulatory history with the FDA. It earned a reputation for severe abuse when it originally came to the market in 1959, and was removed in the 1970s.