This NDA submission sets the stage for the regulatory approval process for MoxDuo IR for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the U.S. MoxDuo IR, an immediate-release Dual OpioidR pain therapy, is a patented 3:2 fixed-ratio combination of morphine and oxycodone.
This NDA submission is based on a full clinical and manufacturing program for MoxDuo IR. As agreed with the FDA, the NDA for MoxDuo IR is being submitted under 505(b)(2) regulations wherein approval for a new drug may be obtained more efficiently because the approval process can rely upon historical data regarding its' already approved components. A 505(b)(2) approval also provides commercial benefits because, in parallel to patents which cover MoxDuo until 2029, it affords to the sponsor additional regulatory market exclusivity, allowing companies to develop a marketing strategy with a brand consumers recognize and may prefer in a potentially wide-open market.
As agreed with the FDA, the NDA manufacturing section filing initiated the NDA review and is classified as an 'early submission', enabling sponsors like QRxPharma to obtain a head-start on the overall review process, with the remaining technical documentation to follow in August. QRxPharma will augment the filing with additional safety information derived from the recently completed Study 022.
The US NDA package will serve as the core component of MoxDuo registration submissions in Europe, Australia, Canada and elsewhere. The company believes Study 022 demonstrating a clinically significant reduction in respiratory depression, the major cause of death from opioids, will be attractive to regulators and prescribers and will also facilitate label claim advantages for MoxDuo IR when the European Marketing Authorization Application (MAA) is submitted in 2012.
The development program included three pivotal phase III studies for the treatment of moderate to severe post-operative pain. In head-to-head comparisons with morphine, oxycodone, Percocet and placebo, more than 700 patients have been treated with MoxDuo IR in seven clinical trials over its successful phase III program. Clinical data have demonstrated that MoxDuo IR achieves equal or better pain relief with fewer incidences of moderate to severe side effects in those comparisons using current standards of care.