Trevena Inc. announced that its partner in China, Jiangsu Nhwa, received formal approval from the National Medical Products Administration for OLINVYK. It has been approved 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. The Chinese regulatory agency (NMPA) accepted the NDA in January 2022.

The approval is based on results of two bridging trials conducted in China and also leveraged US clinical data. Results from the bridging studies demonstrated that the safety, tolerability and pharmacokinetic profile of OLINVYK in Chinese patients is consistent with what has been seen in other OLINVYK clinical trials. Jiangsu Nhwa has an exclusive license agreement for the development and commercialization of OLINVYK in China.

Trevena is due to receive a $3 million milestone payment from Jiangsu Nhwa with the approval. The Company is also eligible to receive $15 million upon first commercial sale of OLINVYK in China, in connection with its non-dilutive royalty-based financing with an affiliate of R-Bridge Healthcare Fund (the R-Bridge Financing). As part of the R-Bridge Financing, Trevena previously received a $15 million upfront payment and may receive an additional $10 million upon achievement of either a commercial or financing milestone.

About OLINVYK® (oliceridine) injection: OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg.