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FDA Advisory Committees again reject Aximris XR for the management of pain.- Intellipharmaceutics International Inc.

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Published:19th Jan 2020
Intellipharmaceutics International Inc. announced that that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted to not support the approval of Aximris XR (oxycodone extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 24 to 2 against the voting question: "Do you recommend approval of Aximiris XR (oxycodone extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate?" There can be no assurance that the FDA will ultimately approve the NDA for the sale of Aximris XR in the U.S. market, or that it will ever be successfully commercialized. Comment: In July 2017 the FDA Advisory Committees rejected Aximiris (then known as Rexista).
Condition: Pain:Moderate to Severe
Type: drug

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