Cipher's Revised NDA for CIP-Tramadol ER Accepted for Review by FDA

Cipher Pharmaceuticals Inc. today announced that its revised New Drug Application (NDA) for CIP-Tramadol ER, its extended-release formulation of tramadol, has been accepted for review by the U.S. Food and Drug Administration (FDA). Cipher expects the review to be completed by October 2008.

In May 2007, the Company received an approvable letter from the FDA pertaining to its original NDA for CIP-TRAMADOL ER. Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act.