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Morphine-Oxycodone Combo Reduces Moderate-to-Severe Pain Following Bunionectomy Surgery
"The path to commercialization 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 MoxDuo IR compared to its individual components," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "We now shift our focus to the final MoxDuo IR registration trial, a study to evaluate the effectiveness of MoxDuo IR 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."
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, randomized comparison of three fixed-dose treatment groups experiencing moderate to severe pain following bunionectomy surgery. Each treatment group received the drug every six hours. The primary endpoint for evaluating the efficacy of MoxDuo IR 12 mg/8 mg versus its milligram components (morphine 12 mg and oxycodone 8 mg) was the difference in pain intensity scores from baseline for each patient over the 48-hour treatment period (SPID(48)). MoxDuo IR demonstrated statistically superior analgesic effect compared to its individual components of morphine (p=0.01) and oxycodone (p=0.01).
MoxDuo IR also demonstrated significantly greater analgesic effect compared to its components during the first day of dosing using the SPID(24) secondary endpoint (the difference in pain intensity scores from baseline for each patient over the first 24-hour treatment period). "With bunionectomy surgery, the most severe pain occurs within the first 24 hours and, accordingly, that's where we observed the greatest benefit of MoxDuo IR relative to its components in terms of pain relief," added Holaday.
To satisfy FDA combination rule testing requirements, the study was designed to compare MoxDuo IR to its milligram components, ie, MoxDuo 12 mg of morphine plus 8 mg oxycodone vs patients treated with either 12 mg morphine alone or 8 mg oxycodone alone. Despite MoxDuo IR delivering twice the morphine equivalent opioid dose, its discontinuation rate (4.7%) due to adverse side effects compared favorably with morphine (2.3%) and oxycodone (4.0%) alone. These data reinforce the improved safety/side effect profile of MoxDuo IR over existing opioid treatments.
The Company's MoxDuo product portfolio includes both immediate and controlled release as well as intravenous formulations. "Our goal is to provide physicians and patients with a variety of complementary Dual-Opioids for managing moderate to severe pain from hospital to home," added Holaday. "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."