ARTICLE | Clinical News

Egalet reports mixed data for abuse-deterrent morphine

August 7, 2014 1:22 AM UTC

Egalet Corp. (NASDAQ:EGLT) said top-line data from two of three bioequivalence trials to treat moderate to severe chronic pain showed that 100 mg Egalet-001 -- an abuse-deterrent, extended-release, oral formulation of morphine -- met one endpoint for bioequivalence to 100 mg MS Contin morphine sulfate controlled-release oral tablets from Purdue Pharma L.P. (Stamford, Conn.), but missed another.

In both Study 067-EG-005 and Study 067-EG-004, Egalet-001 was bioequivalent to MS Contin based on area under the curve (AUC) concentration, but it missed the criteria for bioequivalence based on peak plasma concentration (Cmax). Study 067-EG-005 compared Egalet-001 to MS Contin in 58 patients who fasted, while Study 067-EG-004 compared the products in 52 fed patients. Egalet-001 was well tolerated in both studies. This quarter, Egalet expects data from a third bioequivalence study -- Study 067-EG-006 -- evaluating 15 mg Egalet-001 in a fasted state. ...