ARTICLE | Clinical News

More mixed data for Egalet's analgesic

September 24, 2014 2:05 AM UTC

Egalet Corp. (NASDAQ:EGLT) said 15 mg Egalet-001 missed one endpoint for bioequivalence to 15 mg MS Contin morphine sulfate controlled-release oral tablets from Purdue Pharma L.P. (Stamford, Conn.). In Study 067-EG-006, Egalet-001 met bioequivalence criteria based on area under the curve (AUC) concentration but did not meet bioequivalence criteria based on maximum plasma concentration (Cmax). A 100 mg dose of the compound missed similar criteria in two previous bioequivalence trials (see BioCentury, August 6).

Egalet said it will need to run more trials and hopes to meet with FDA next quarter to discuss a registration path. A Phase III trial of Egalet-001 in individuals with chronic low back pain is slated to begin enrollment in 1Q15, and an NDA is planned for mid-2016. Prior to the results from the trio of bioequivalence studies, Egalet had hoped to submit an NDA to FDA in 4Q14 under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products. ...