BioCentury
ARTICLE | Clinical News

FDA reviewing AcelRx's pain candidate

May 25, 2018 6:31 PM UTC

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) said FDA accepted for review an NDA for Dsuvia sufentanil sublingual tablet (ARX-04) to treat moderate to severe acute pain in medically supervised settings. Its PDUFA date is Nov. 3.

The company received a complete response letter in October for the candidate, which delivers a sublingual formulation of sufentanil via a disposable, prefilled, single-dose applicator (see BioCentury, Oct. 13, 2017)...

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