Milnacipran

[webslave]

Drug Relieves Fibromyalgia Pain: Study

NEW YORK (Reuters Health) - An antidepressant medication helps reduce pain in people with fibromyalgia, a chronic pain condition for which there is currently no approved treatment, according to the results of a study reported Friday.

The lead investigator told Reuters Health that he hopes to begin the last phase of studies required before a company can apply for U.S. Food and Drug Administration approval later this year.

Fibromyalgia is a chronic condition marked by widespread muscular and joint pain, as well as specific "tender" points that typically occur in the neck, spine, hips and shoulders. Other symptoms include sleep disturbances and fatigue, depression and irritable bowel syndrome. The condition affects an estimated 2% to 4% of the population, but is seen most often in women of reproductive age.

The pain associated with the syndrome does not originate from trauma, inflammation, or nerve damage, but seems to be due to a disturbance in pain processing that originates in the brain.

There are no approved drug therapies for fibromyalgia, but it is usually treated with tricyclic antidepressants. Those drugs cause dry mouth, weight gain and other side effects.

Milnacipran, the drug being studied to treat fibromyalgia, is approved to treat depression in 22 countries, including France and Japan. Milnacipran belongs to a class of drugs called norepinephrine serotonin reuptake inhibitors (NSRIs). It is hoped it will be more successful in treating fibromyalgia, said lead investigator Dr. Daniel Clauw, director of the University of Michigan's Chronic Pain and Fatigue Research Program.

In the study, 125 volunteers were randomly assigned to take an inactive placebo or milnacipran once or twice daily. The participants had fibromyalgia for 5 to 7 years on average, said Clauw.

Patients who received the twice-daily dose had a statistically significant improvement in pain. Thirty-seven percent reported at least a 50 percent reduction in pain intensity compared with 14 percent of placebo patients. Seventy percent of all milnacipran-treated patients reported overall improvement compared with 36 percent of placebo patients.

The most commonly reported side effect was nausea. About 27 percent of volunteers dropped out of the study, but that was no higher than expected, said Clauw, who presented the results at the annual meeting of the American Pain Society.

Cypress Bioscience Inc., based in San Diego, California, licensed the North American rights to the drug from France's bioMerieux Pierre Fabre in August 2001.

With the promising results in hand, Cypress hopes to begin phase III studies late this year, said Clauw, who is also chairman of Cypress' Rheumatology Advisory Board, and has a interest -- financially and scientifically -- in seeing milnacipran receive U.S. Food and Drug Administration approval.

[Richard.N]

This undoubtedly great news for people without voiding dysfunction, but isn't Effexor an NSRI? I had great difficulty and frequency AT THE SAME TIME on that drug

[hodologica]

I've been web-studying this and just want to add a few things.
1. it is definitely contraindicated to urinary difficulty.
2. it now appears to be available in the US.
3. it has been available 6 yrs in europe and asia and no one has spontaneously combusted on it or whatever. Source did not say how many people had used it on those continents.
4. no sexual side effects
5. apparently affects noradrenaline (norepinephrine) 3x more than serotonin, whereas Effexor effects serotonin 30x more than it does noradrenaline.
6. heres a good primer: http://www.biopsychiatry.com/milnacipran.htm

This is not medical advice and I am nothing more than a smart kid w/ a computer, but I think ill be trying this, not Elavil (amitryptaline) or other TCAs, if PT does not help my pain enough. I think I'll also use it rather than SSRIs if my chronic prostatitis / chronic pelvic pain syndrome emotional roller-coaster becomes intolerable.