Cipher Receives FDA Response to CIP-TRAMADOL ER Appeal

Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding its appeal of the Agency's Approvable Letter for CIP-TRAMADOL ER, Cipher's extended-release formulation of tramadol. In the response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the Division's approvable action. Cipher is currently evaluating the response and is expecting to have further dialogue with the FDA in the near future, following which the Company will determine its next step, which may include appealing the decision to the next supervisory level at the FDA (represented by Dr. John Jenkins, Director, Office of New Drugs, Center for Drug Evaluation and Research).