Source: DGNews  |  Posted 2 years ago

By Roberta Friedman, PhD

SAN FRANCISCO -- May 26, 2009 -- Milnacipran appears effective for the treatment of fibromyalgia independent of its action as an antidepressant, researchers stated here at the 162nd Annual Meeting of the American Psychiatric Association (APA).

Yves Mainguy, MD, Pierre Fabre Medicament, Boulogne, France, presented the results of the multicentre, 19-week, double blind, placebo-controlled trial on May 20 at a poster presentation.

The trial included 884 patients, aged 18 to 70 years, without significant psychiatric conditions as determined by the Mini International Neuropsychiatric Interview. Patients were not depressed, as determined by the Brief Depression Inventory (BDI) rating scale.

The patients had to stop using any psychoactive drugs commonly prescribed for fibromyalgia.

The primary endpoint was a composite responder rate for recalled pain and Patient Global Impression of Change (PGIC). Various pain, anxiety, sleep, fatigue, and cognitive questionnaires contributed to secondary endpoints.

Patients were randomised to a placebo (n = 449) or milnacipran 200 mg/day (n = 435) for 12 weeks of fixed-dose exposure after a 4-week dose-escalation phase.

At week 16, investigators used a sequential testing in which step 1 consisted of individuals with at least 30% improvement from baseline on their 24-hour recall of pain and a rating of "very much improved" or "much improved" on the PGIC scale.

Patients were also compared on the Fibromyalgia Impact Questionnaire (FIQ) total score for their mean change from baseline.

A larger percentage of composite responders was seen in the milnacipran than in the placebo group (P = .0003). The milnacipran group also showed greater improvement in FIQ total score (P = .015).

Nausea and headache were the most commonly reported adverse events reported with milnacipran. Men taking milnacipran reported testicular or scrotal pain or dysuria. Withdrawals from the study because of adverse events occurred in 22.3% of milnacipran-treated patients and 9.9% of placebo-treated patients.

The drug was approved this year by the US Food and Drug Administration and is awaiting corresponding approval in Europe.

Funding for this study was provided by Pierre-Fabre Medicament.

[Presentation title: Efficacy Of Milnacipran in Fibromyalgia Is Independent of Antidepressant Properties: A European Multicenter, Double-Blind, Placebo-Controlled Trial. Abstract NR6-016]