NMPA (China) approves Olinvyk to treat acute pain.- Trevena Inc.,
Trevena, Inc. a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, 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 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.
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