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Forest milnacipran development continues

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Forest is continuing development of its serotonin-norepinephrine reuptake inhibitor milnacipran for fibromyalgia despite the agent's failure to show statistical significance in an initial Phase III pivotal trial, the firm reports Sept. 28. "Although the results [of the 888-patient study] did not achieve statistical significance at the p<0.05 level, the planned development program…will continue," Forest says. The program includes an ongoing Phase III trial as well as "a soon to be initiated" additional Phase III study. Forest had projected an NDA submission at the end of 2006, but now states that "upon further analysis" of the results it "will be in a position to better assess what impact these results will have on the timing of an NDA." Forest is jointly developing milnacipran with Cypress Bioscience under a 2004 agreement (1Pharmaceutical Approvals Monthly December 2004, In Brief)...
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