Milnacipran and fibromyalgia
by Nathan Wei, MD, FACP, FACR
Nathan Wei is a nationally known board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.
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Milnacipran belongs to a class of drugs known as serotonin/norepinephrine reuptake inhibitors, or SNRIs, which exert their effect by blocking the reuptake of norepinephrine and serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. Norepinephrine may also play a role in pain regulation.
Data from Forest Pharmaceuticals
Milnacipran was studied in a Phase 2 trial. The Phase II trial was a three-month randomized placebo-controlled study involving 14 sites. Fibromyalgia patients were randomized to either the milnacipran treatment or a placebo. The primary factor evaluated was patient-reported pain. A PDA (electronic diary) was used to record daily pain.
In the phase II trial, milnacipran was shown to lead to a significant improvement in pain. Thirty-seven percent of the milnacipran-treated patients, randomized to the twice a day dosing group, reported at least a 50 percent reduction in pain compared to 14 percent of the patients on the placebo. Further, 75 percent of all milnacipran-treated patients reported an impression of improvement compared to 38 percent of the placebo group. This was also significant. Milnacipran was generally
well tolerated, especially with twice-daily dosing. The most common dose-related events reported by patients were nausea, noted early in the study, as well as a slight increase in heart rate. Most events were mild to moderate in intensity.
In a Phase III trial, 888 patients were randomized to a double-blind placebo-controlled study with milnacipran versus a placebo. The primary end point included both an assessment of pain as well as the patient’s global impression of improvement. This endpoint, although not statistically significant (p=0.06), showed a positive trend. The magnitude of the treatment effect observed at three months was maintained at six months. A secondary end point looking at physical function did not show statistically significant improvement.
Milnacipran was generally well tolerated with the most common adverse events being nausea in 6 percent, heart rate increase in 2 percent, headache in 2 percent and depression in 2 percent.
Milnacipran (Savella) has been approved by the FDA for treatment of fibromyalgia.
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