Trevena’s OLINVYK Approved in China; Shares Soar 320%
Trevena, Inc. (Nasdaq: TRVN) has received approval from the Chinese National Medical Products Administration (NMPA) for OLINVYK, for the management of acute, severe pain in adults.
Jiangsu Nhwa has an exclusive license agreement for the development and commercialization of OLINVYK in China.
The company’s share price rose more than 320% following the news.
Highlights
The NMPA approval is based on results of two bridging trials conducted in China which demonstrated the safety, tolerability and pharmacokinetic profile of OLINVYK in Chinese patients, and is consistent with what has been seen in other OLINVYK clinical trials.
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.As part of this 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.
OLINVYK is a new chemical entity approved by the FDA in August 2020. It contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for abuse, similar to other opioids.
About Trevena
Trevena, Inc. is a biopharmaceutical company developing and commercializing innovative medicines for patients with CNS disorders. The company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Trevena’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
