At an FDA Anesthetic and Analgesic Drug Products Advisory Committee meeting, the Committee voted eight against, and seven in favor of, the approval of Trevena’s oliceridine drug for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted.
“We continue to believe that the totality of evidence presented and discussed today supports the utility of oliceridine as a new analgesic option for the management of moderate to severe acute pain for patients in hospitals or other controlled clinical settings,” said Carrie L. Bourdow, president and chief executive officer. “Trevena is committed to working closely with the FDA as they complete their review of the NDA for oliceridine.”
The Advisory Committee reviewed data from oliceridine’s full clinical development program with a focus on the Phase 3 Apollo 1 and Apollo 2 efficacy studies, as well as the Phase 3 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.
Oliceridine is a G-protein biased mu-opioid receptor (MOR) ligand in development for the management of moderate to severe acute pain in hospitals or other controlled clinical settings and where intravenous (IV) therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company has requested that oliceridine be classified as a Schedule II controlled substance.
(Source: Trevena, Inc.)