QRxPharma Limited announced submission of its New Drug Application (NDA) clinical data package to the United States Food and Drug Administration (FDA) for MoxDuo IR, an immediate-release 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 18 July and is currently under review. The Company believes submission of the clinical data from MoxDuo IR's successful phase III clinical programme completes its NDA filing requirements; the FDA typically takes 10-12 months to review these applications. 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 commercialisation 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,” said Dr John Holaday, managing director and chief executive officer, QRxPharma. “We are pleased to have met this significant NDA milestone in just four years, and look forward to the regulatory approval process that may enable product sales in 2012.”
This completed NDA submission is based on a full non-clinical, clinical and manufacturing program for MoxDuo IR, and is being filed under 505(b)(2) regulations wherein approval for a new drug may be expedited by citing historical published evidence supporting each of MoxDuo's already approved components to supplement the data derived from the robust QRxPharma development programme. Consistent with the United States Federal Code of Regulations and as agreed with the FDA, the Company previously initiated the NDA review process by filing its completed CMC module in July 2011.
The company has requested a Priority (accelerated) FDA review for MoxDuo IR based on favourable 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 III programme. 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 US 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 Authorisation Application (MAA) is submitted in 2012.
QRxPharma Limited 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.