QRxPharma completes phase III trial, prepares for NDA

Pain treatment specialist, QRxPharma, is gearing up for a New Drug Application (NDA) with the US Food and Drug Administration following the completion of its third pivotal phase III registration trial of its dual opioid, MoxDuo.

The double-blind trial was conducted in the US, and compared a flexible dose regimen of MoxDuo versus a fixed low dose. It found patients on the flexible dose experienced a significant reduction in pain compared to the fixed dose.

Read more about QRxPharma.

“This is a major milestone for QRxPharma," said QRxPharma CEO and Managing Director, Dr John Holaday.

"We not only achieved the primary analgesic endpoint, but also believe the basic clinical requirements for NDA filing have been satisfied. We can see the goal line.”

MoxDuo is a dual opioid, consisting of a 3:2 ratio of morphine and oxycodone. The two opioids operate via different neurochemical mechanisms and have a complementary effect with reduced side effects compared to taking just one opioid.

In the wake of the positive trial results, QRxPharma has lined up a pre-NDA meeting with the FDA, which is scheduled to occur on 22 March.

“Our upcoming pre-NDA meeting with the FDA will explore QRxPharma’s regulatory strategy and provide preliminary feedback about the sufficiency of our studies to set the stage for MoxDuo approval,” said Holaday.

The company believes it has met the basic clinical data requirements for an NDA, and is still aiming for a filing in the first half of this year.

QRxPharma (ASX:QRX) saw a 1.5% bump in its share price in early trading this morning, reaching $1.35 as of 11am.