FDAnews
www.fdanews.com/articles/101426-qrxpharma-doses-first-patients-in-phase-iii-trial

QRxPharma Doses First Patients in Phase III Trial

November 26, 2007

Australian drugmaker QRxPharma has begun treating patients in the first of several studies in the Phase III development program for its lead product candidate Q8003IR, an immediate release dual-opioid pain therapy.

The double-blind, placebo-controlled study will compare the efficacy and safety of four different dosage strengths of Q8003IR with placebo.

The study will take place at eight U.S. sites and will enroll 250 patients experiencing moderate to severe pain following a bunionectomy.

A safety extension trial will capture longer-term patient safety data in support of the planned new drug application data submission package, QRxPharma said.