QRxPharma Starts Pivotal Phase 3 Study Of MoxDuoIR

QRxPharma has initiated registration in the pivotal (Study 008) Phase 3 study of MoxDuoIR for moderate to severe acute pain. The company expects to complete dosing by close of Q2 2010.

The purpose of the current Phase 3 registration study (008) is to replicate these differences in a larger trial, one with sufficient statistical power to achieve on the primary and secondary endpoints. If successful, this trial will satisfy the Combination Rule requirement of the FDA and will also serve as a registration study.

The double-blind, randomised and repeat fixed-dose study compares MoxDuoIR’s reduction in pain intensity (primary endpoint) to component doses of oxycodone and morphine in patients experiencing moderate to severe post-operative pain over 48 hours. The study is targeted to enroll 522 patients (with 174 in each treatment group) at six US clinical research sites.

The primary endpoint for evaluating the efficacy of MoxDuoIR 12mg/8mg versus its milligram components of morphine 12mg and oxycodone 8mg administered every six hours is the difference in pain intensity scores for each patient group over the 48-hour treatment period.

In addition, the secondary endpoints includes efficacy relating the patient’s global assessment of effect (ie extent of overall pain relief) as well as amount of supplemental analgesia (acetaminophen) used throughout the treatment period; and safety as measured by incidence and intensity of opioid-related adverse effects. QRxPharma incorporated input from the FDA regarding the design and statistical analysis of this study.

The final Phase 3 registration trial is scheduled to begin Q1 2010. No additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval. QRxPharma expects to complete its Phase 3 program Q3 2010 and file its NDA for MoxDuoIR by EOY 2010.

John Holaday, managing director and CEO of QrxPharma, said: “We recently reported clinical studies demonstrating the superiority of MoxDuoIR in terms of tolerability compared to equi-analgesic doses of morphine, oxycodone and Percocet for the management of acute post-operative pain.

“These studies demonstrated that MoxDuoIR provides significant pain relief and fewer side effects (nausea, vomiting, dizziness and constipation). We are now addressing a regulatory requirement for New Drug Application (NDA) approval of MoxDuoIR, ie, demonstration that it is superior in efficacy to its individual components.”