CHESTERBROOK, Pa., Jan. 27, 2022 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced 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.
CHESTERBROOK, Penn., Aug. 30, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the acceptance of two abstracts at ANESTHESIOLOGY® 2021. Both abstracts highlight safety data from the OLINVYK (oliceridine) injection program. The meeting is sponsored by the American Society of Anesthesiologists and will be held on October 8th to 12th in San Diego, California.
CHESTERBROOK, Pa., Aug. 25, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced Wake Forest Baptist Health Medical Center will join the VOLITION (“Intravenous Oliceridine and Opioid Related Complications”) study which examines the impact of OLINVYK (oliceridine) injection on respiratory, gastrointestinal (GI), and cognitive function outcomes in the postoperative setting. Ashish K. Khanna, FCCM, FCCP, M.D., Associate Professor of Anesthesiology, Wake Forest School of Medicine, will serve as the lead investigator at this hospital.
CHESTERBROOK, Pa., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that oliceridine has been classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration (DEA). With DEA scheduling now complete, the Company expects to make OLINVYK available for distribution in November.
Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist.
Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.
CHESTERBROOK, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the Company’s partner in China has been approved by the Chinese National Medical Products Administration (NMPA) to initiate clinical trials for IV oliceridine, Trevena’s lead investigational asset for the management of moderate-to-severe acute pain. Jiangsu Nhwa holds an exclusive license agreement for the development and commercialization of oliceridine in China.
A year and a half after being rebuffed, microcap biotech Trevena is heading back to the FDA in a second bid to win approval for its opioid painkiller.
Trevena announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine, the Company’s lead investigational asset for the management of moderate-to-severe acute pain.
The FDA put out its in-house assessment of Trevena’s new pain med, now up for review, and at first blush it’s not looking good for the biotech today.