Milnacipran for Fibromyalgia

Fibromyalgia Syndrome (FMS) is a tricky condition that has kept scientists and physicians guessing for over a hundred years. Symptoms of FMS include chronic and widespread pain throughout the body, severe fatigue and poor sleep. At first thought to be psychosomatic, current evidence on FMS now points to a real disorder of the nervous system. This chronic pain syndrome is estimated to affect 4-6% of the general population, making it the second most commonly diagnosed arthritic condition to osteoarthritis. And yet, the U.S. Food and Drug Administration (FDA) has yet to approve any drug for the treatment of FMS.

In 2002, a Phase II trial entitled "Milnacipran Significantly Improves Pain and Fatigue in Fibromyalgia Syndrome Patients," was conducted by Milnacipran's American manufacturer, Cypress Bioscience, Inc. Milnacipran (also known as Ixel and Midalcipran) is the first in a new class of antidepressants known as Norepinephrine Serotonin Reuptake Inhibitors (or NSRI's). Unlike Prozac or Effexor, milnacipran regulates norepinephrine and serotonin equally in order to alleviate chronic pain more effectively.

The trial was initially conducted on 95 patients in 2002. Though an additional 30 patients very recently completed a similar study; their results have not yet been disclosed. Patients were randomized to receive placebo or Milnacipran (either once or twice per day) for four weeks of dose escalation, followed by eight weeks of constant dose.

The initial Phase II trial found that patients who took milnacipran twice a day showed statistically significant improvements in pain reduction compared to those who received placebo. Of the 95 patients that had completed the trial as of the date of this analysis, 87 percent of all milnacipran-treated patients reported overall improvement, compared to 33 percent in the placebo group. In addition, milnacipran-treated patients showed significant improvements in fatigue and depressed mood.

Milnacipran is perhaps the first step towards a greater development of treatments for FMS sufferers. Although Milnacipran has yet to be approved by the FDA for use in FMS management, the Phase III trials currently underway will hopefully result in fast FDA approval.