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Anesthetic and Analgesic Drug Products Advisory Committee

On Thursday, October 11, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met to discuss a new drug application (NDA) for oliceridine (0.1 mg/milliliter and 0.35 mg/milliliter), submitted by Trevena, Inc. (Trevena), proposed for the management of moderate-to-severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted. The committee was asked to discuss the efficacy and safety data and benefit-risk considerations.

A narrow majority of the committee, 8 of 15 members, recommended that the FDA should not approve oliceridine for the proposed management of moderate-to-severe acute pain in adults for whom an IV opioid is warranted.