QRxPharma, a specialty pharmaceutical company, has successfully completed a Phase III program pilot study comparing the efficacy and safety profile of MoxDuo IR against component doses of morphine and oxycodone.
In this randomized, double blind study of 197 patients at six US clinical research sites, MoxDuo IR was compared to morphine and oxycodone in managing acute pain during the first 24 hours following a scheduled surgical procedure. When postoperative pain reached a measure of at least four on the numerical pain rating scale, patients received either MoxDuo IR, morphine or oxycodone every six hours for 48 hours.
According to QRxPharma, results demonstrated that MoxDuo IR reduces pain significantly more than its component doses; further, when compared to equianalgesic doses of morphine and oxycodone, MoxDuo IR produced fewer and less intense side effects.
These results confirm 12mg/8mg morphine plus oxycodone combination as the preferred dose for optimal efficacy and tolerability as well as provide sample size guidance for the upcoming Phase III combination rule study required for new drug application submission in 2010, the company said.
In terms of reduced pain intensity scores and other related measures, the analgesic effects of 12mg/8mg MoxDuo IR were 80-100% greater than the components, morphine or oxycodone. The 6mg/4mg MoxDuo IR dose also showed similar improvements when compared to its individual components, the company added.
Additional studies evaluating MoxDuo IR versus Percocet in patients with joint replacement surgery are underway, with results expected in third quarter of 2009.
John Holaday, CEO of QRxPharma, said: Completed ahead of schedule and on budget, trial data clearly demonstrated the clinical and commercial value of our patented Dual-Opioid, with the potential to give patients greater tolerability than morphine or oxycodone alone. From these data, we are confident that our upcoming Phase III Combination Rule study will prove successful.