Trevena announces submission of NDA in China for Olinvyk by its partner Jiangsu Nhwa Pharmaceutical for management of acute pain.

The NDA was submitted by Trevena’s partner, Jiangsu Nhwa Pharmaceutical, and follows completion by Nhwa of a Phase III bridging trial for Olinvyk (oliceridine) injection, a novel IV analgesic that has been approved in the United States by the 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.

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 III 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 III 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.