FDA accepts QrxPharma’s revised MoxDuo NDA

QRxPharma (ASX:QRX) will hear by late August whether the US FDA approves its resubmitted application for pain patch MoxDuo.

The regulatory agency has set a PDUFA (Prescription Drug User Fee Act) date of 26 August for QRxPharma’s New Drug Application.

In the United States, the PDUFA date is the deadline by which the FDA will decide on approving new prescription drugs.

QRxPharma was dealt a setback in late June last year after the FDA knocked back its initial application for MoxDuo IR, the immediate release variant of the company’s dual-opioid pain patch.

The FDA had issued a Complete Response note, indicating that the agency needed additional safety and efficiency data to make its decision.

But despite concerns that QRxPharma would have to conduct new clinical trials, blowing out the approval process further, the FDA instead asked the company to conduct additional analysis of the trial data already available.

“We are pleased that the FDA has formally accepted our resubmitted MoxDuo NDA,” QRxPharma CEO Dr John Holaday said. “We expect the advisory committee meeting to be scheduled between late June and late July, and will update shareholders once formal notification has been received.”

QRxPharma is also at the clinical trial stage for MoxDuo CR, a controlled-release version of the patch.

MoxDuo is a 3:2 formulation of morphine and oxycodone for moderate to severe pain.

QRxPharma shares were trading 0.43% lower at $1.145 as of around 1:30 pm on Friday.