Streamline for QRxPharma
Tuesday, 05 August, 2008
The US Food and Drug Administration has granted approval to QRxPharma's [ASX: QRX] streamlined Phase III development plan for lead candidate Q8003IR.
This approval means that QRxPharma will be required to conduct only two Phase III trials for New Drug Agreement [NDA] filing. No additional pharmacology, toxicology or long term clinical safety studies will be required.
Q8003IR is an immediate release dual-opioid containing both morphine and oxycodone, and is intended to be used in the management of moderate to severe pain.
The FDA did make some changes to QRxPharma's proposal, but according to company representatives these changes were minimal.
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