FDA panel votes in favor of AcelRx's pain candidate
FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil sublingual tablet (ARX-04) from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) supports its approval to manage moderate to severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults in a medically supervised setting. The resubmitted NDA has a Nov. 3 PDUFA date.
AcelRx received a complete response letter from FDA in October 2017 for the candidate, which delivers a sublingual formulation of sufentanil via a disposable, prefilled, single-dose applicator...
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