FDA says more studies needed for Cipher's acne drug

Last Updated: 2007-08-13 9:00:38 -0400 (Reuters Health)

TORONTO (Reuters) - Cipher Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration concurred with one of its divisions that a further clinical study was needed to demonstrate the safety of its treatment for severe acne, CIP-Isotretinoin.

Cipher said it was reviewing the FDA's response "to determine the most appropriate path forward to achieve approval."

An FDA official had written to Cipher to say the FDA agreed with the view of its Division of Dermatology and Dental Products that further study of the drug was required.

Earlier this year, the company said its new drug application related to CIP-Isotretinion, a formulation of the acne medication isotretinoinis, was approvable subject to two outstanding issues -- a question on chemistry, manufacturing and controls, and a request for additional clinical data.

But Cipher argued that the clinical question raised was "adequately addressed" in its drug submission. This prompted the company to file an appeal with the FDA.

The company has not said when it hopes to launch the product.

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