Milnacipran hydrochloride: its efficacy, safety and tolerability profile in fibromyalgia syndrome

Milnacipran is a serotonin-norepinephrine reuptake inhibitor (SNRI), although its norepinephrine reuptake inhibition predominates. It has been marketed in Europe and Japan as an antidepressant for many years, but only recently has it been investigated as a treatment for fibromyalgia syndrome (FMS). Both open-label and double-blind, placebo-controlled trials have confirmed its efficacy in FMS, not only on the pain component but also on the fluctuating array of other symptoms such as sleep and cognitive disturbances and fatigue The phase III trials have employed comprehensive composite endpoints to more accurately capture the many complex domains of FMS. Milnacipran's efficacy was not limited to the shortterm, 12-week trials. It also demonstrated durability of response for up to 1 year. Its safety and tolerability were typical of its class, and it was generally well tolerated. Further work will be required to establish its place in FMS therapy by comparing it directly with other agents.