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FDA panel rebuffs Insys' analgesic

May 22, 2018 10:45 PM UTC

An FDA panel voted 18-1 that the benefits of Buvaya buprenorphine sublingual spray from Insys Therapeutics Inc. (NASDAQ:INSY) do not outweigh its risks, and thus recommended against the analgesic’s approval. The vote came at a joint meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee.

In briefing documents issued ahead of Tuesday's meeting, FDA reviewers said data from the NDA of Buvaya do not support its usage to treat acute pain (see BioCentury Extra, May 18)...

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