Planned FDA review of QRxPharma's MoxDuo delayed to allow assessment of new data

26 June 2013

Australia-based QRxPharma (ASX: QRX) today (June 26) advised that the planned July 17 US Food and Drug Administration (Advisory Committee meeting to consider the firm’s MoxDuo (morphine and oxycodone) combination opioid analgesic New Drug Application will be delayed in order to allow the company and the FDA time to fully consider results of recent findings for Study 022.

The NDA was re-filed in late February 2013, with the original Advisory Committee meeting scheduled for July 17 and the Prescription Drug User Fee Act (PDUFA) date was 26 August 2013. Last year, the FDA issued a complete response letter on the NDA for MoxDuo, which is partnered with US generics drugmaker Actavis (NYSE: ACT) for commercialization in the US market, calling for additional information regarding the safety and effectiveness of the combination drug (The Pharma Letter June 29, 2012).

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