Item 8.01 Other Events.
On January 27, 2022, the Company issued a press release announcing that China's
National Medical Products Administration (NMPA) has accepted submission of a New
Drug Application (NDA) for oliceridine injection. The NDA was submitted by
Trevena's partner, Jiangsu Nhwa Pharmaceutical, and follows completion by Nhwa
of a Phase 3 bridging trial for OLINVYK (oliceridine) injection, a novel IV
analgesic that has been approved in the United States by the Food and Drug
Administration (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. A copy of the press release is filed as Exhibit 99.1
to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Number Description
99.1 Press Release dated January 27, 2022
104 The cover page from this Current Report on Form 8-K, formatted in Inline XBRL
© Edgar Online, source Glimpses