Cipher: phase 3 study of CIP-Tramadol for pain fails to meet endpoint

By Lisa Kerner

Charlotte, N.C., Sept. 11 - Cipher Pharmaceuticals, Inc. said efficacy results from its 02.05 phase 3 study of CIP-Tramadol ER for pain in 860 patients did not achieve a statistically significant effect relative to a placebo or the primary endpoint of measured pain intensity.

A higher than anticipated placebo effect was observed in the control arm of the double-blind, randomized, fixed-dose trial.

However, all three active treatment groups in the 12-wwek study demonstrated a reduction in pain from baseline, according to a company news release.

Cipher said its New Drug Application for the drug has been accepted for review by the Food and Drug Administration.

The trial was the latest of a series of six phase 3 trials completed by the Mississauga, Ont.-based drug-development company.

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