Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has completed patient enrolment in its Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin, which is used in the treatment of severe, nodular acne. The Phase III safety study is being conducted under a Special Protocol Assessment that was granted by the U.S. Food and Drug Administration (FDA). The study is a randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product. A total of 931 patients were enrolled in the trial, of which 626 have completed treatment to date.
"This is the largest, most comprehensive trial conducted on isotretinoin, and we are pleased that the clinical investigators, working with our internal team, met this important clinical milestone on target," said Dr. Jason Gross, Cipher's Vice President of Scientific Affairs. "Following an estimated six-month treatment period, the last subject enrolled should complete treatment in April 2011. We expect to have top-line study results in early Q3 2011, which would be followed by an FDA submission in Q4 2011."
Mr. Larry Andrews, President and CEO of Cipher, added: "Isotretinoin remains the most effective treatment for severe, nodular acne. 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. We look forward to completing this final clinical study as Cipher and its partner, Ranbaxy Pharmaceuticals, work toward commercialization of the product in the $700 million U.S. isotretinoin market."
Tiny molecule offers hope in reducing opioid side effects