Morphine/Oxycodone Combo Drug, Moxduo, Resubmitted for FDA Review
Company anticipates launch before end of the year (Feb. 28)
A new drug application (NDA) has been resubmitted to the FDA for Moxduo (QRxPharma), a combination of morphine and oxydocone, for the treatment of acute pain. The agency requested the resubmission of the NDA to include the respiratory safety results from a pivotal clinical trial, Study 022.
According to the drug’s developer, the primary safety advantage of Moxduo over its components is a reduction in respiratory risk. In addition, Moxduo was associated with less vomiting and a lower incidence of other side effects than comparable analgesic doses of morphine or oxycodone.
In addition to the results from Study 022, the revised NDA includes results from five other phase II and phase III clinical trials conducted over the past 6 years showing less nausea, vomiting, itching, and headache in patients treated with Moxduo.
The FDA confirmed that there were no efficacy or safety issues in any of the studies that were part of the original NDA. The resubmitted application, including the new results from Study 022, will undergo review by an advisory committee to evaluate the approvability of Moxduo in the management of acute pain.
The drug’s developer anticipates a commercial launch before the end of the year.
Source: QRxPharma; February 28, 2013.