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FDA rejects Insys Therapeutics sublingual opioid spray

US regulators FDA building

The FDA has rejected Insys Therapeutics buprenorphine sublingual spray due to concerns about the safety of the Arizona-based company’s opioid painkiller.

The US regulator’s decision has come after the FDA advisory committee voted 18-1 against approval of the treatment. The American company sought approval for the sublingual spray, which uses the active ingredient buprenorphine, for the treatment of moderate to severe acute pain earlier this year. However the FDA has rejected the application due to potential safety concerns.

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