Required for FDA new drug application (NDA) submission, this combination rule study – comparing the efficacy and safety profiles of MoxDuoIR against component doses of morphine and oxycodone alone – demonstrated that MoxDuoIR reduces moderate to severe pain following bunionectomy surgery significantly better than its individual components.
Reportedly, the Phase 3 trial enrolled 522 patients at six US clinical research sites, with a high completion rate (94%). The study was conducted as a double-blind, randomised comparison of three fixed-dose treatment groups experiencing moderate to severe pain following bunionectomy surgery. Each treatment group received drug every six hours.
The primary endpoint for evaluating the efficacy of MoxDuoIR 12mg/8 mg versus its milligram components (morphine 12 mg and oxycodone 8mg) was the difference in pain intensity scores from baseline for each patient over the 48-hour treatment period (SPID48). MoxDuoIR demonstrated statistically superior analgesic effect compared to its individual components of morphine and oxycodone.
MoxDuoIR also demonstrated greater analgesic effect compared to its components during the first day of dosing using the SPID24 secondary endpoint (the difference in pain intensity scores from baseline for each patient over the first 24-hour treatment period).
To satisfy FDA combination rule testing requirements, the study was designed to compare MoxDuoIR to its milligram components, ie, MoxDuo 12mg of morphine plus 8mg oxycodone vs patients treated with either 12mg morphine alone or 8mg oxycodone alone.
John Holaday, managing director and CEO of QRxPharma, said: “The path to commercialisation is clear. With the successful completion of this pivotal trial, we believe we have satisfied the FDA’s ‘combination rule’ requirement and clearly demonstrated the efficacy superiority of MoxDuoIR compared to its individual components.
“With the successful completion of our first pivotal trial, we are able to quantitatively demonstrate the value of this product to potential partners, prescribers and patients.
“We now shift our focus to the final MoxDuoIR registration trial, a study to evaluate the effectiveness of MoxDuoIR in patients following total knee replacement surgery which is projected to complete dosing in Q3 2010. Based on earlier pilot study data, we are confident the second pivotal trial will also yield statistically significant results, enabling the company to file its NDA in Q4 2010.”