Submission supported by data from a Phase 3 bridging study of oliceridine injection compared to IV morphine, conducted in China by Nhwa

Trevena is eligible to receive future success payments upon approval and commercialization milestones, as well as a 10% royalty on net sales in China

CHESTERBROOK, Pa., Jan. 27, 2022 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that China's National Medical Products Administration (NMPA) has accepted submission of a New Drug Application (NDA) for oliceridine injection. The NDA was submitted by Trevena's partner, Jiangsu Nhwa Pharmaceutical, and follows completion by Nhwa of a Phase 3 bridging trial for OLINVYK (oliceridine) injection, a novel IV analgesic that has been approved in the United States by the Food and Drug Administration (FDA) for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

"We are pleased to see the data presented in Nhwa's NDA submission are consistent with data from our registration studies in the US," said Carrie Bourdow, President and CEO of Trevena. "We are confident that Nhwa is the right strategic partner to advance OLINVYK in China and believe that this collaboration has the potential to create significant value for our stakeholders over the years ahead."

Trevena executed an exclusive License Agreement in 2018 with Nhwa to develop, manufacture, and commercialize OLINVYK in China and is eligible to receive regulatory and commercial milestone payments as well a 10% royalty on net sales in China.

Nhwa's submission to the NMPA included data from two clinical bridging studies in Chinese patients, based on feedback from China's NMPA: a dose-escalation, open-label, single-dose study to evaluate the pharmacokinetics and safety profile; and a randomized, double-blind, positive-controlled Phase 3 bridging study in subjects with moderate to severe acute pain after abdominal surgery to evaluate the analgesic efficacy and safety of OLINVYK compared with IV morphine.

The results of the Phase 3 bridging study show that the safety and pharmacokinetic profile of oliceridine in Chinese patients is consistent with the data from global studies and demonstrates safety and tolerability in Chinese populations. The launch of OLINVYK in China, if approved by the NMPA, will help to address the significant unmet need in acute pain management.