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ARTICLE | Clinical News

FDA issues CRL for Insys' analgesic

August 3, 2018 5:43 PM UTC

Insys Therapeutics Inc. (NASDAQ:INSY) said FDA issued a complete response letter for buprenorphine sublingual spray to treat acute pain. Insys was seeking the candidate's approval for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

In May, an FDA panel voted 18-1 that the benefits of buprenorphine sublingual spray do not outweigh its risks, and thus recommended against the analgesic’s approval (see "FDA Panel Votes No for Insys' Analgesic")...

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Insys Therapeutics Inc.