The preliminary top-line results from an 888 patient randomized, double blind, placebo-controlled pivotal Phase III study of milnacipran as a treatment for fibromyalgia (FMS) conducted by Forest Laboratories, Inc. and Cypress Bioscience, Inc. did not achieve statistical significance.

Although the results did not achieve the required results at the p<0.05 level the planned development programme for milnacipran, which includes an ongoing Phase III study and a soon to be initiated additional Phase III study by Forest Laboratories, will continue.

At this time the Companies have only been able to review initial top-line results and further analysis must be completed in the coming months to confirm these development plans, states a company release.

FMS is a chronic and debilitating condition characterised by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms.

Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors, or NSRIs, which exerts its effect by preferentially inhibiting the reuptake of norepinephrine over serotonin, two neurotransmitters known to play an essential role in regulating pain and mood.