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Pivotal Studies Show Milnacipran Reduces Fibromyalgia Pain: Presented at WCP

By Sara Freeman

GLASGOW, United Kingdom -- August 25, 2008 -- The dual action serotonin-norepinephrine reuptake inhibitor (SNRI) milnacipran at a dose of 100 or 200 mg daily eases the widespread muscle pain associated with fibromyalgia, according to data from 2 pivotal phase 3 studies.

These double-blind, placebo-controlled trials, which involved over 2,000 randomised patients treated for 3 to 6 months, were presented on August 20 at the 12th World Congress on Pain (WCP).

"Milnacipran is approved for use in several European countries and Japan as an antidepressant," study investigator Daniel J. Clauw, MD, University of Michigan, Ann Arbor, Michigan, said in an interview.

He noted that the 2 studies showed that the efficacy of milnacipran in fibromyalgia pain works independently of its antidepressant actions. They also add to the evidence that SNRIs, like tricyclic antidepressants, have a direct analgesic effect.

Although milnacipran is currently not available in North America, Dr. Clauw said data presented at WCP on the use of the drug in fibromyalgia have been submitted to the US Food and Drug Administration.

In the first study, 401 patients were randomised to placebo, 399 patients to milnacipran 100 mg, and 396 patients to milnacipran 200 mg. The majority of the patients were women, and the mean age was approximately 50 years in each group. On average, patients had fibromyalgia for close to 10 years.

In the second study, 223 patients were randomised to placebo, 224 patients received milnacipran 100 mg, and 441 patients received milnacipran 200 mg.

A composite primary endpoint was used in both studies, which defined responders as those with a 30% or greater improvement in pain, a patient global impression of change score of 1 (very much improved) or 2 (much improved), and a 6-point or greater improvement from baseline in physical function assessed using the Short-Form 36 Physical Function subscale.

Treatment with milnacipran at both doses produced significantly greater improvements in the primary endpoint at both 3 and 6 months. Improvements were seen after 1 month of treatment, with maximum benefits seen after about 9 weeks.

Nausea and headache were the most commonly reported adverse events, with nausea occurring in about 35% to 40% of milnacipran-treated patients compared with 19% of placebo-treated patients. Headache occurred in 15% to 17% and 11% of patients, respectively. Nearly all of the adverse events reported were rated as mild to moderate.

Approximately 10% of placebo-treated and up to 25% of milnacipran patients withdrew from the studies due to adverse effects.

Nevertheless, these data hold promise for the treatment of fibromyalgia, and the drug is both "safe and effective," the researchers concluded.

Funding for these studies was provided by Forest Laboratories Inc. and Cypress Bioscience Inc.

[Presentation titles: Milnacipran for the Treatment of Fibromyalgia: Results From a 3-Month, Double-Blind, Placebo-Controlled Trial. Abstract PW188]and [Treatment With Milnacipran Improves the Symptoms of Fibromyalgia: Results From a 6-Month, Double-Blind, Placebo-Controlled Trial. Abstract PW187]

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