Clinical Trials

QRxPharma has received FDA approval to proceed with Phase III clinical trials for MoxDuo® IR (Q8003IR) in the US. This program will involve two separate studies.

The primary endpoint of the Phase III study is establishing statistically significant pain relief in patients with chronic moderate to severe pain taking MoxDuo IR versus patients taking placebo.

In addition to its primary endpoint, QRxPharma has defined secondary endpoints that are aimed at testing the robustness and performance of MoxDuo IR, and that will allow for marketing and labelling that clearly differentiates the use of MoxDuo IR  over use of morphine or oxycodone alone.

QRxPharma believes that its labelling claims will significantly differentiate the safety and therapeutic effectiveness of its Dual Opioid® products from traditional moderate to severe pain therapies.