On Friday, October 12, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met to discuss the resubmission of a new drug application (NDA) by AcelRx Pharmaceuticals, Inc. (AcelRx) for DSUVIA (sufentanil sublingual tablet 30 mcg), proposed for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients, in a medically supervised setting. The committee was asked to discuss risk-benefit considerations and whether this product should be approved.

A majority of the committee, 10 of 13 members, voted that the benefits of DSUVIA, with the Risk Evaluation and Mitigation Strategies (REMS) proposed by the FDA, outweigh the risks for the proposed moderate-to-severe pain indication, supporting its approval.