BioCentury
ARTICLE | Clinical News

Cip-isotretinoin regulatory update

December 5, 2011 8:00 AM UTC

Cipher submitted to FDA an amendment to its NDA for Cip-isotretinoin to treat severe, nodular acne. The company expects a 6-month review for the application. Cipher said the amendment includes data from a double-blind, North American Phase III trial that showed 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 (see BioCentury, June 27). In a 2007 approvable letter, FDA said an additional clinical trial would be necessary to establish the compound's safety (see BioCentury, May 7, 2007). ...