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news.Cipher Pharmaceuticals has reached the enrollment mid-point in its Phase III safety study of CIP-Isotretinoin, a new, patented formulation of isotretinoin, which is used in the treatment of severe, nodular acne. To date, more than 400 patients have been enrolled.
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The Phase III safety study is randomised, double-blinded trial comparing the safety profile of CIP- Isotretinoin to an FDA-approved, commercially available isotretinoin product.
The study is currently being conducted at 50 sites in the US and Canada with a planned duration of 18 months. The study is being conducted under a special protocol assessment that was granted by the FDA.
Cipher Pharmaceuticals said that the milestone triggers a $2m milestone payment from Ranbaxy Pharmaceuticals, Cipher’s US marketing and distribution partner.
Jason Gross, vice president of scientific affairs at Cipher, said: “Our clinical investigators are doing an excellent job in patient recruitment and follow-up and we are pleased with the study’ s progress. We look forward to working closely with Ranbaxy Pharmaceuticals as we advance this pivotal clinical study and prepare to submit the findings to the FDA.”