Trevena announced that the Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 8-7 against the approval of oliceridine injection for the management of moderate to severe acute pain in adults for whom an intravenous (IV) opioid is warranted.
Oliceridine, a G-protein biased mu-opioid receptor (MOR) ligand, has a unique mechanism of action that allows for more selective pathway activation while avoiding a pathway associated with opioid-related adverse events.
The AADPAC reviewed data from the Phase 3 APOLLO 1 and APOLLO 2 efficacy studies, and from the Phase 3 ATHENA open-label safety study that was designed to reproduce real-world settings in which oliceridine would be used for various surgical and medical acute pain conditions. The data demonstrated all dose regimens achieved their primary endpoint of statistically greater analgesic efficacy than placebo. Also, treatment with oliceridine led to comparable pain relief with numerically fewer frequent adverse events (eg, vomiting) when compared with an IV morphine regimen.
The Prescription Drug User Fee Act (PDUFA) target date has been set for November 2, 2018. The FDA is not bound by the Committee’s recommendation but takes it into consideration when making its decision. If approved, the Company has requested that the drug be classified as a Schedule II controlled substance.
“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.”
For more information visit Trevena.com.