Australian Biotechnology News

QRxPharma kicks off pivotal trial for MoxDuo

Phase III trial for MoxDuo IR in the U.S. with final trial to begin in 2010.
Tags | QRxPharma | MoxDuo | investigational new drug | FDA | clinical trials

Sydney-based pharmaceutical company, QRxPharma, has initiated a Phase III trial for its flagship product, analgesic MoxDuo IR (immediate release).

The trial, which will be conducted at six sites in the U.S., will seek to build upon positive results found in a previous trial completed earlier this year.

MoxDuo is a compound of two existing drugs, morphine and oxycodone, and QRxPharma hope to reinforce prior trial findings that it maintains high efficacy in pain relief with fewer side effects, such as nausea and constipation, than either of the two components drugs taken singularly.

If the trial is successful in replicating the effects of the previous trial, it will satisfy the Food and Drug Administration's (FDA) rules for combination products and serve as a registration study.

Another Phase III registration study of MoxDuo IR is scheduled for Q1 2010, which, if successful, could be the final trial before market approval by the FDA.

QRxPharma (ASX:QRX) is up 9.6% to 85.5c in today's trading.

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