Hospice Medication Update: Morphine/Oxycodone Combination Product (MoxDuo® IR) Expected in 2012
Posted by Dr. Julia Harder
A few months back, we informed you of a new product that was moving closer to FDA approval: a combination product containing immediate-release morphine and immediate-release oxycodone in a 3:2 ratio called MoxDuo® IR. Now, generic manufacturer Actavis has partnered with QRxPharma and has announced their intention to launch MoxDuo® IR in the third quarter of 2012.
The New Drug Application submitted to the FDA includes results from three pivotal Phase 3 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. Clinical data have consistently demonstrated that MoxDuo® IR achieves equal or better pain relief with fewer incidences of moderate to severe side effects, notably a clinically significant reduction in respiratory depression.
MoxDuo® IR is part of a larger dual opioid portfolio including intravenous (MoxDuo® IV) and controlled release (MoxDuo® CR) formulations. These formulations are designed to incorporate tamper resistance and reduced abuse liability as appropriate.