Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Buprenorphine Sublingual Spray

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In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject INSYS Development Company’s new drug application for buprenorphine sublingual spray for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate because the risks of the drug outweigh the benefits.