QRxPharma announced that the FDA Anesthetic and Analgesic Drug Products Advisory Committee has voted against recommending the revised New Drug Application (NDA) for Moxduo (morphine sulfate and oxycodone hydrochloride). Moxduo’s proposed indication is for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
The panel cited insufficient evidence of a safety benefit for Moxduo when compared to each of its individual ingredients, as well as a lack of support for Moxduo’s decreased risk of respiratory suppression when compared to taking morphine or oxycodone alone.
If approved by the FDA, Moxduo would be the only immediate release fixed-ratio combination oral capsule containing two active opioid ingredients. A decision by the FDA is expected by May 25, 2014.
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