FDA Advisory Committee rejects MoxDuo for Moderate to Severe Pain - QRxPharma

QRxPharma announced that the FDA Anesthetic and Analgesic Drug Products Advisory Committee has voted (14-0) to recommend against approval of Moxduo (morphine plus oxycodone), an immediate release Dual Opioid for the treatment of Moderate to Severe Acute Pain. The Advisory Committee found the Company did not provide sufficient evidence to warrant approval of Moxduo at this time.The FDA has never before approved a prescription combination medicine composed of two drugs from the same pharmacologic class with the same mechanism of action. The FDA is expected to make a decision by 25 May on the MoxDuo NDA.