Cipher completes CIP-Isotretinoin enrolment
Cipher Pharmaceuticals (TSX:DND) has completed patient enrolment in a Phase 3 safety study of its CIP-Isotretinoin treatment of severe, nodular acne.
A total of 931 patients were enrolled in the trial, of which 626 have completed treatment to date. Following an estimated six-month treatment period, the last subject enrolled should complete treatment in April, 2011, with top-line study results expected in the third quarter of 2011. The study is comparing the safety profile of CIP-Isotretinoin to a commercially available isotretinoin product under a Special Protocol Assessment from the FDA.
“We believe our product’s unique attributes, particularly the more consistent absorption profile, would provide a significant advancement in the treatment of this disease and offer dermatologists an excellent alternative,” CEO Larry Andrews said in a statement. The Cipher drug is partnered with Ranbaxy Pharmaceuticals.