FDA Advisory Committee negative for oliceridine to treat moderate to severe acute pain.- Trevena Inc.

Trevena, Inc. announced the outcome of the meeting of the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to review and discuss oliceridine. At the meeting, the Advisory Committee voted 8 against, and 7 in favor of, the approval of oliceridine for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted.

The Advisory Committee reviewed data from oliceridine�s full clinical development program with a focus on the Phase III APOLLO 1 and APOLLO 2 efficacy studies, as well as the Phase III ATHENA open-label safety study that was intended to emulate real world use of oliceridine in a broad spectrum of surgical and medical acute pain conditions. In controlled clinical trials, oliceridine demonstrated efficacy compared to placebo along with a safety and tolerability profile consistent with the class. Trevena�s New Drug Application (NDA) submission for oliceridine was accepted for review by the FDA on January 2, 2018 with a Prescription Drug User Fee Act (PDUFA) target date for completion of review by the FDA of November 2, 2018. The FDA is not bound by the Advisory Committee's recommendations but takes its advice into consideration when making its decision.

Comment:.Trevena has asserted that oliceridine is safer than currently available intravenous opioids, pointing to the drug's mechanism of action as a key differentiating factor. Briefing documents from the FDA, however, revealed the agency had not agreed to Trevena's plans to measure oliceridine's impact on respiratory safety burden.