Milnacipran Approved for Fibromyalgia!

[TMJA_Stacy]

FDA Approves Milnacipran for Fibromyalgia

by Susan Jeffrey

January 15, 2009 — Forest Laboratories and Cypress Bioscience announced January 14 that the Food and Drug Administration (FDA) has approved milnacipran (Savella), a dual serotonin- and norepinephrine-reuptake inhibitor (SNRI), for the management of fibromyalgia.

Efficacy of the drug was established in 2 pivotal US phase 3 trials, the companies note in a press statement. Treatment with 100-mg/day and 200-mg/day doses demonstrated "statistically significant and clinically meaningful" concurrent improvements in pain, patient global assessment, and physical function, the statement adds.

The companies expect the drug to be available in pharmacies by March 2009.

Fibromyalgia, characterized by widespread pain and decreased physical function, affects as many as 6 million people in the United States, according to estimates from the American College of Rheumatology, the statement notes.

Although the exact mechanism of the benefit of milnacipran in this setting is not known, "some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia," the release states. Milnacipran blocks reuptake of serotonin and norepinephrine, with greater selectivity for norepinephrine in vitro. "This may be the mechanism by which [milnacipran] acts to improve the symptoms of fibromyalgia."

Phase 3 Trials

Data to support this indication were taken from 2 phase 3 trials that used a "composite responder analysis," the statement states. "This end point required individual patients to demonstrate concurrent improvement to multiple validated measures, including pain (visual analog scale), patient global assessment (patient global impression of change), and physical function (Short Form-36 Physical Component Summary)," the companies note.

The phase 3 trials, 6 months and 3 months in duration respectively, included 2084 patients, 1460 treated with milnacipran and 624 with placebo. In both studies, a greater proportion of patients treated with 100 or 200 mg/day of milnacipran had at least a 30% reduction in pain from baseline and rated themselves as "very much improved" or "much improved" on the patient global assessment. More treated patients also met criteria for treatment response by concurrent improvements in pain, physical function, and patient global assessment.

The treatment was safe and generally well tolerated. The most frequently occurring adverse reaction was nausea; other common reactions included constipation, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, and hypertension. The majority of these reactions were mild to moderate in nature, the statement adds."



This drug has been on the radar for a while. It has been approved in Europe for depression for over 10 years. Glad to see another drug approved for the treatment of fibromyalgia, especially one that, according to the numbers in the studies mentioned, should help a lot of people!
stacy