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FDA Rejects Oxycodone/Morphine Combo (Moxduo) for Treatment of Acute Pain

Efficacy and safety data are insufficient

The FDA has issued a complete response letter (CRL) regarding the new drug application (NDA) for Moxduo (oxycodone/morphine, QRx Pharma Limited) for the treatment of moderate-to-severe acute pain.

In its letter, the agency stated that there was not sufficient evidence to support approval of the drug at this time. The FDA indicated that clinical information demonstrating a clear benefit over oxycodone and morphine alone, either by efficacy or safety, in an appropriate patient population is needed.

In April, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously (14 to 0) not to approve Moxduo for the treatment of moderate-to-severe acute pain.

In his summary, the committee chairman stated: “It is the sense of this committee that the applicant has not provided sufficient evidence to support a claim that Moxduo is safer than morphine and oxycodone. The primary failing was in study design and the inability of the committee to be able to rely with confidence on multiple post-hoc analyses. Future more appropriately designed studies would be helpful in specifically answering the question. The committee does not suggest that Moxduo is either beneficial or not beneficial. The committee simply feels that the evidence is insufficient to make a determination either way.”

Sources: Pipeline Review; May 27, 2014; and Moxduo Status Overview; May 2014.

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