BioCentury
ARTICLE | Clinical News

Cip-isotretinoin: Phase III data

June 27, 2011 7:00 AM UTC

Top-line data from the per protocol (PP) population (n=813) of a double-blind, North American Phase III trial showed that Cip-isotretinoin met the co-primary endpoints of non-inferiority to an undisclosed marketed isotretinoin product in the change from baseline in total nodular lesion count at week 20 and in the proportion of patients who achieve a >=90% reduction in the total number of nodular lesions. An intent-to-treat (ITT) last observation carried forward (LOCF) analysis of all 925 patients in the trial showed that Cip-isotretinoin met the first co-primary endpoint, but missed the second endpoint. The most common side effects were dry skin and dry lips. Cipher has an SPA from FDA for the trial. ...