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.”