QRxPharma Limited announced submission of its New Drug Application (NDA) clinical data package to the U.S. Food and Drug Administration (FDA) for MoxDuo IR, a Dual Opioid pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone.
The NDA Chemistry, Manufacturing and Controls (CMC) module was submitted to the FDA on July 18 and is under review. The company believes submission of the clinical data from MoxDuo IR’s Phase 3 clinical program completes its NDA filing requirements. The NDA filing is the basis for US regulatory approval of MoxDuo IR for the treatment of moderate to severe pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US.
“Since QRxPharma’s initial public offering in 2007, we have strived towards an aggressive commercialization strategy for MoxDuo—one that streamlined development timelines, was capital efficient, demonstrated clinical advantages of the product, and set the stage for commercial benefits to the company,” says John Holaday, MD, managing director and chief executive officer, QRxPharma.
The company has requested a priority (accelerated) FDA review for MoxDuo IR based on favorable clinical data from several head-to-head comparisons with morphine, oxycodone, Percocet and placebo. To date, more than 700 patients have been treated with MoxDuo IR in seven clinical trials over the company’s successful Phase 3 program. Clinical data have consistently demonstrated that MoxDuo IR achieves equal or better pain relief with fewer incidences of moderate to severe opioid related side effects compared to current standards of care.
The NDA package will serve as the core component of MoxDuo registration submissions in Europe, Australia, Canada and elsewhere. The company believes the recently completed Study 022 which demonstrated a clinically significant reduction in respiratory depression, the major cause of death from opioids, will be attractive to strategic partners, regulators and prescribers. This study will be submitted to the FDA as part of a 2011 NDA update filing and will also facilitate label claim advantages for MoxDuo IR when the European Marketing Authorization Application (MAA) is submitted in 2012.
Release Date: August 25, 2011
Source: QRxPharma Limited
Filed Under: Drug Discovery