QRxPharma resubmits MoxDuo NDA in US again
QRxPharma (ASX:QRX) is taking its third run at securing US approval for dual-opioid pain treatment MoxDuo.
The company announced it has resubmitted its MoxDuo New Drug Application (NDA) with the US FDA for a second time.
Last month, QRxPharma met with the FDA to discuss the regulator’s issue of a second Complete Response Letter (CRL) regarding the NDA. The company was told that the safety and efficacy of the drug are not in question, but that the FDA requires additional analysis of data on the respiratory safety advantage of MoxDuo from one particular study.
Since the second CRL, QRxPharma has conducted an analysis of over 30 million data points for oxygen desaturation from the study in question. In a statement, QRxPharma CEO Dr John Holaday said the new analysis should be enough for approval.
“We are confident that our refiled NDA will confirm the validity of the data defining the product’s respiratory safety advantages and we are hopeful that the FDA will view them favourably,” he said. “We were encouraged by our candid dialogue with the FDA throughout this process, and will continue to liaise closely with the agency to bring MoxDuo to market.”
The US FDA now has until late May to decide whether to approve the resubmitted NDA, Holaday said. “Assuming approval, we anticipate product launch with our US commercialisation partner, Actavis, in the second half of 2014.”
QRxPharma (ASX:QRX) shares were trading unchanged at $0.595 as of around 1.30 pm on Tuesday.
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