QRxPharma announced that it has resubmitted a New Drug Application (NDA) to the FDA for MoxDuo (morphine and oxycodone) for the treatment of moderate to severe acute pain. The FDA requested the resubmission of the NDA to include the respiratory safety results of Study 022.
The resubmitted clinical data demonstrated the safety advantages of MoxDuo over its components, morphine and oxycodone, and that MoxDuo provides as good or better analgesia as indicated by past studies involving more than 1,600 patients experiencing moderate to severe acute post-operative pain. The primary safety advantage of MOXDUO over its components is a reduction in respiratory risks evident in the data from Study 022.
For more information call (908) 506-2900 or visit http://www.qrxpharma.com