Bedminster, New Jersey and Sydney, Australia -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announces the successful completion of the first of two pivotal Phase 3 studies for MoxDuoŽIR, an immediate-release Dual-Opioid(TM) pain therapy. Required for FDA New Drug Application (NDA) submission, this combination rule study - comparing the efficacy and safety profiles of MoxDuoŽIR against component doses of morphine and oxycodone alone - demonstrated that MoxDuoŽIR reduces moderate to severe pain following bunionectomy surgery significantly better than its individual components.
"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 MoxDuoŽIR compared to its individual components," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "We now shift our focus to the final MoxDuoŽIR registration trial, a study to evaluate the effectiveness of MoxDuoŽIR 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, 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 MoxDuoŽIR 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 (SPID48). MoxDuoŽIR demonstrated statistically superior analgesic effect compared to its individual components of morphine (p=0.01) and oxycodone (p=0.01).
MoxDuoŽIR 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 MoxDuoŽIR relative to its components in terms of pain relief," added Holaday.
To satisfy FDA combination rule testing requirements, the study was designed to compare MoxDuoŽIR 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 MoxDuoŽIR delivering twice the morphine equivalent opioid dose, its discontinuation rate (4.7%) due to adverse side effects compared favourably with morphine (2.3%) and oxycodone (4.0%) alone. These data reinforce the improved safety/side effect profile of MoxDuoŽIR over existing opioid treatments.
The Company's MoxDuoŽ 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(TM) 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."
For more information:
Alicia Moran, 410-991-7027, [email protected]
Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements that are not historical facts; they include statements about our beliefs and expectations. Any statement in this release that states our intentions, beliefs, expectations or predictions (and the assumptions underlying them) is a forward-looking statement.
These statements are based on plans, estimates and projections as they are currently available to the management of QRxPharma. Forward-looking statements therefore speak only as of the date they are made, and we undertake no obligation to update publicly any of them in light of new information or future events.
QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management and central nervous system (CNS) disorders. For more information, visit www.qrxpharma.com.
/PRNewswire -- April 15/