Trevena Inc TRVN shares are skyrocketing today as the China National Medical Products Administration approved Olinvyk (oliceridine) for managing acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Jiangsu Nhwa has an exclusive license agreement for developing and commercializing Olinvyk in China.
The Chinese regulatory agency accepted the marketing application in January 2022. The approval is based on the results of two bridging trials conducted in China and also leveraged U.S. clinical data.
Related: Trevena Post Op Pain Management Drug Cuts Hospital Stay Length Vs. Patients On Opioids.
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.
With the approval, Trevena is due to receive a $3 million milestone payment from Jiangsu Nhwa. The company is also eligible to receive $15 million upon the first commercial sale of Olinvyk in China in connection with its non-dilutive royalty-based financing with an affiliate of R-Bridge Healthcare Fund.
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.
Price Action: TRVN shares are up 298.5% at $2.57 on the last check Monday.
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