FDA Advisory Panel Votes Down Intellipharmaceutics’ Abuse-Deterrent Opioid

A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse.

The Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 22-1 against Rexista (oxycodone HCl) oral tablets, as indicated for moderate to severe pain treatment. Committee members cited incomplete safety and efficacy data.

The sole dissenter, Scott Novak, an epidemiologist at RTI International, said he believed the drug is no less safe than existing Oxycontin products.