FDA delays approval of QRxPharma's pain drug MoxDuo

29 June 2012

The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application for Australia-based QRxPharma’s (ASX: QRX) MoxDuo (morphine and oxycodone) in the treatment of moderate to severe acute pain.

This was viewed as a major blow for the company, with its shares tumbling more than 56% to A$0.74. The drug is partnered with Actavis (now part of Watson Pharmaceuticals) for commercialization in the $2.5 billion US acute pain market (The Pharma Letter December 21, 2011).

QRxPharma is presently considering its response to the requests for additional information with regard to the safety and effectiveness of MoxDuo and has been granted a meeting with the FDA to clarify the steps required for approval. The company did not indicate if the agency had requested additional clinical trials of the combination drug.

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