BioCentury
ARTICLE | Clinical News

Forest, Cypress report milnacipran Phase III data

December 9, 2008 2:43 AM UTC

Forest (NYSE:FRX) and Cypress (NASDAQ:CYPB) said milnacipran met both co-primary composite endpoints in the Phase III MLN-MD-03 trial to treat fibromyalgia syndrome. On the first endpoint, significantly more patients in the milnacipran group experienced >=30% reduction in pain from baseline and rated themselves as "very much improved" or "much improved" based on the Patient Global Impression of Change (PGIC) vs. placebo (p<0.001). On the second endpoint, significantly more patients in the milnacipran group had concurrent improvements in pain, PGIC and physical function as measured by >=6 point improvement in the SF-36 Physical Component Summary (PCS) vs. placebo (p<0.001). The double-blind, placebo-controlled, North American trial included 1,025 patients. ...