QRxPharma files for NDA on MoxDuo
Monday, 18 July, 2011
QRxPharma has reach another milestone with the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its dual-opioid pain killer, MoxDuo IR.
MoxDuo IR is the “immediate release” formulation of QRxPharma’s flagship dual-opioid therapy and is composed of a 3:2 ratio of morphine and oxycodone. It has shown in clinical trials to have a similar or better effect on controlling pain with less side-effects than either morphine or oxycodone alone.
The submission is 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, namely morphine and oxycodone.
It also offers QRxPharma market exclusivity until 2029, in parallel with the company’s patents on the formulation.
The filing is classified as an “early submission,” allowing QRxPharma to get a head start on the review process with additional technical documentation to follow later in the year.
Later this year, QRxPharma will augment the filing with additional safety information derived from a recently completed clinical trial, which the company believes demonstrates a clinically significant reduction in respiratory depression, the major cause of death from opioids, when using MoxDuo IR.
The company (ASX:QRX) was trading at $1.70 as of 1pm, up 3% on Friday’s close.
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