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ARTICLE | Clinical News

Oct. 11 advisory committee meeting for Trevena's pain candidate

September 14, 2018 5:25 PM UTC

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet Oct. 11 to discuss an NDA for Olinvo oliceridine (TRV130) from Trevena Inc. (NASDAQ:TRVN) for the management of moderate to severe acute pain in adult patients for whom an IV opioid is warranted. The NDA's PDUFA date is Nov. 2.

Last year, Trevena said Olinvo met the primary endpoints in the Phase III APOLLO-1 and APOLLO-2 trials to treat moderate to severe acute pain following bunionectomy and abdominoplasty, respectively (see “Olinvo: Ph III APOLLO-1 Data” & “Olinvo: Ph III APOLLO-2 Data”)...

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