Cipher Pharmaceuticals Inc. (TSX: DND) today provided top-line safety and efficacy results from the Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin for the treatment of severe, nodular acne. The 925-patient study was a randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to a commercially available isotretinoin product.
Summary of Results
From a safety perspective, the top-line data was positive showing no overall statistical differences in the adverse event profile between the two products. The most frequent side effects that were observed were dry skin and dry lips. In addition, initial statistics on psychiatric disorders, eye disorders, ear disorders, musculoskeletal, vascular disorders, cardiac disorders, and gastrointestinal disorders, illustrate there are no significant differences in the extent of adverse events between CIP-ISOTRETINOIN and the reference product.
The efficacy component of the study had two co-primary endpoints: (1) the total change in lesion counts between baseline and at the end of week 20; and (2) the total number of subjects that had at least a 90% clearing at the end of 20 weeks of treatment. These two co-primary endpoints were analyzed using the per-protocol population (PP) as well as the intent-to-treat population (ITT). The PP analysis comprised all subjects who completed the study according to the protocol. In this analysis both co-primary endpoints met the non-inferiority margins established for the study. The ITT population comprised all subjects who entered the study, including those who did not conclude the study for whatever reason. Those who dropped out early were assigned treatment efficacy scores based on the last observation recorded for that subject, also known as last observation carried forward (LOCF). In the LOCF analysis of the ITT population, the first primary endpoint was achieved while the second endpoint fell slightly outside the non-inferiority margin target.
"These results show CIP-ISOTRETINOIN has a safety profile that mirrors commercially available isotretinoin products, which was the key outcome we were hoping for from this study," said Dr. Jason Gross, Cipher's Vice President of Scientific and Medical Affairs. "In addition, this comprehensive study yielded valuable and substantial efficacy data to support our FDA submission later this year."
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