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FDA reviewers cast doubt on Insys analgesic's utility, safety

May 18, 2018 7:21 PM UTC

FDA reviewers said data from an NDA of Buvaya buprenorphine sublingual spray from Insys Therapeutics Inc. (NASDAQ:INSY) do not support its usage to treat acute pain. The remarks came in briefing documents issued ahead of a May 22 joint meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to review the NDA.

Insys is 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. Panelists at the meeting are to vote on whether Buvaya's benefits outweigh its risks. Buvaya's PDUFA date is July 28...

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Insys Therapeutics Inc.