MISSISSAUGA, ON, June 15 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND)
today announced that it has received notice from the U.S. Food and Drug
Administration (FDA) that the Company will not be required to complete a Phase
I trial to investigate the potential for a clinically relevant interaction
between CIP-TRAMADOL ER, its once-daily, sustained release formulation of the
pain medication tramadol, and high levels of alcohol. At the request of the
FDA, Cipher had planned to undertake a Phase I study in the third quarter of
2006. The results of this study were to be filed with the FDA as a supplement
to the Company's New Drug Application (NDA) for CIP-TRAMADOL ER.
