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news.QRxPharma has filed a new drug application (NDA) clinical data package of MoxDuo IR with the US Food and Drug Administration (FDA) as a treatment for moderate to severe pain.
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MoxDuo IR is an immediate-release Dual Opioid pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone.
The company’s NDA Chemistry, Manufacturing and Controls (CMC) module is currently on FDA review.
QRxPharma has requested a priority (accelerated) FDA review for MoxDuo IR based on positive clinical data from several head-to-head comparisons with morphine, oxycodone, Percocet and placebo.
In the company’s Study 022, the drug has showed reduction in respiratory depression which will support the company to submit European marketing authorisation application (MAA) in 2012.
QRxPharma managing director and CEO John Holaday said they look forward to the regulatory approval process that may enable product sales in 2012.