Cipher not required to complete phase 1 trial, moves NDA submission to second quarter

By Lisa Kerner

Charlotte, N.C., June 15 - The Food and Drug Administration notified Cipher Pharmaceuticals Inc. that it is not required to complete a phase 1 trial investigating a clinically relevant interaction between CIP-Tramadol ER, its once-daily, sustained release formulation of the pain medication tramadol, and high levels of alcohol.

Cipher said it had planned to undergo the phase 1 study in the third quarter and include the results in its supplemental New Drug Application.

"This notification from the FDA moves us another step closer on the regulatory path to final approval for CIP-Tramadol ER," president Larry Andrews said in a company news release.

"We are on track to submit our NDA in the second quarter, which represents one of several important milestones we expect to achieve this year for our three late-stage products."

Located in Mississauga, Ont., Cipher is a drug development company.

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