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ARTICLE | Clinical News

FDA panel votes no for Insys' analgesic

May 25, 2018 5:01 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 the meeting, FDA reviewers said data from the NDA of Buvaya do not support its usage to treat acute pain. The reviewers wrote that efficacy data showed Buvaya's superiority to placebo, but were concerned with its "later than optimal" onset of analgesia for an acute pain medication as well as the high need for rescue analgesics. Reviewers also noted higher rates of nausea, vomiting and dizziness with Buvaya compared with morphine and oxycodone...

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