Trevena Says FDA Accepts Painkiller Marketing Application For Review; Stock Up

(RTTNews) - Trevena Inc. (TRVN) said that the U.S. Food and Drug Administrationhas accepted the Company's New Drug Application or NDA for OLINVO or oliceridine Injection. The Company expects that the PDUFA date for the NDA will be in the fourth quarter of 2018.

OLINVO is an investigational product for the management of moderate to severe acute pain. It is the first G protein biased ligand of the mu receptor designed to provide IV opioid pain relief with fewer associated adverse effects.

OLINVO is a next generation IV analgesic for the management of moderate-to-severe acute pain in the hospital and similar settings and has been granted Breakthrough Therapy designation by the FDA. OLINVO was specifically designed to deliver the pain relief of a conventional IV opioid, with fewer associated adverse effects via its biased ligand mechanism of action.

In Phase 2 and Phase 3 clinical trials, OLINVO provided rapid and powerful analgesic efficacy while demonstrating a wider therapeutic window compared to morphine, suggesting it may be highly effective and well-tolerated for patients in need of strong analgesia. OLINVO is an investigational product and has not been approved by the FDA or any other regulatory agency. The Company expects OLINVO to be a Schedule II controlled substance.

TRVN closed Tuesday's regular trading at $1.80, up $0.20 or 12.50%. In the after-hours trade, the stock further gained $0.44 or 24.44%.