QRxPharma advances with NDA for MoxDuo IR

It’s one of the final steps in bringing a new drug to market or, in QRxPharma’s case, a new combined formulation of two existing drugs, morphine and oxycodone, in its MoxDuo IR pain therapy.

It’s the New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and QRxPharma has announced its NDA submission, including clinical data, was submitted to the FDA in July and is now under review.

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The NDA submission is based on a full non-clinical, clinical and manufacturing program for MoxDuo IR, and is being filed under 505(b)(2) regulations where approval for a new drug may be expedited by citing historical published evidence supporting each of MoxDuo’s already approved components to supplement the data derived from QRxPharma’s development program.

“Since QRxPharma’s initial public offering in 2007, we have strived towards an aggressive commercialisation strategy for MoxDuo – one that streamlined development timelines, was capital efficient, demonstrated clinical advantages of the product, and set the stage for commercial benefits to the company,” said Dr John Holaday, Managing Director and Chief Executive Officer, QRxPharma.

“We are pleased to have met this significant NDA milestone in just four years, and look forward to the regulatory approval process that may enable product sales in 2012.”