BioCentury
ARTICLE | Clinical News

Egalet-001: Clinical trial data

August 11, 2014 7:00 AM UTC

Top-line data from a pair of pivotal bioequivalence trials - Study 067-EG-005 and Study 067-EG-004 - showed that 100 mg Egalet-001 met the criteria for bioequivalence to 100 mg MS Contin morphine sulfate controlled-release oral tablets based on AUC concentration, but missed the criteria for bioequivalence to 100 mg MS Contin based on Cmax concentration. Study 067-EG-005 compared Egalet-001 to MS Contin in 58 patients in a fasted state, while Study 067-EG-004 compared the products in 52 fed patients. Egalet-001 was well tolerated in both studies with no serious adverse events reported. This quarter, Egalet expects data from a third bioequivalence trial - Study 067-EG-006 - evaluating 15 mg Egalet-001 in a fasted state. ...