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news.The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Australia-based QRxPharma's Moxduo new drug application (NDA) for the treatment of moderate to severe acute pain.
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FDA stated that currently there is no sufficient evidence to support approval of QRxPharma’s pain drug Moxduo.
According to FDA, clinical information showing a clear benefit over oxycodone and morphine alone, either by efficacy, or safety, in an appropriate patient population, is necessary.
Currently, the company is reviewing the FDA’s feedback and will request a meeting with them to clarify the steps required for approval of the drug.
QRxPharma chief executive officer Edward Rudnic said, "We will work with FDA to develop a clinical program that addresses the Agency’s feedback and ensure that the completed program will clearly demonstrate Moxduo’s benefit."
The company is mainly focused on the development and commercialization of new pain management and abuse prevention products.
QRxPharma’s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risks and improved patient outcomes.
The company has entered into strategic agreements with Actavis, Paladin Labs, Aspen Group and Teva Pharmaceuticals for the commercialization of immediate release Moxduo in the US, Canada, Australia (including New Zealand and Oceania), South Africa and Israel.