Cip-isotretinoin: Completed Phase III enrollment

Cipher completed enrollment of 931 patients in a double-blind, North American Phase III trial comparing Cip-isotretinoin vs. an undisclosed marketed isotretinoin product. Cipher has an SPA from FDA for the trial. 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). ...