On Tuesday, June 26, 2018, a majority of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee voted to recommend against the approval of Pain Therapeutics’ Remoxy ER (oxycodone extended-release capsules).

The proposed indication of Remoxy ER is the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have properties that deter abuse by the intranasal and intravenous routes of abuse, based on physicochemical properties of its formulation.

A majority of the Joint Committee, 14 of 17 members, voted that the efficacy, safety and risk-benefit profile of Remoxy ER do not support its approval.