BioCentury
ARTICLE | Clinical News

AcelRx's Dsuvia gets CRL

October 13, 2017 7:52 PM UTC

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) said FDA issued a complete response letter for its NDA for Dsuvia sufentanil sublingual tablet to treat moderate-to-severe acute pain in medically supervised settings. The CRL is the second the company has received for a sublingual formulation of sufentanil.

AcelRx said FDA requested additional data on at least 50 patients to assess Dsuvia's safety at the proposed maximum dose and recommended a human factors study to validate changes to its directions for use. The company hopes to meet with FDA concerning a resubmission...

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