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Article: Cipher announces enrollment of first patient in CIP-ISOTRETINOIN Phase III safety study.(Clinical report)
- Article from:
- Biotech Week
- Article date:
- October 21, 2009
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Cipher Pharmaceuticals Inc. (TSX: DND) announced that it has enrolled the first patient 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 (see also Drug Development).
The study is randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product. The study will be conducted at 50 sites in the U.S. and Canada, and is expected to enroll more than 800 patients over an 18-month period. The study is being conducted under a Special Protocol Assessment ("SPA") that was granted ...