|  Milnacipran Significantly Improves Pain and Fatigue in Fibromyalgia Syndrome Patients. FMS (Fibromyalgia Syndrome) is a condition affecting approximately 3-8 million Americans, 80-90% of whom are women. Also formerly known as fibrositis, chronic muscle pain syndrome, psychogenic rheumatism, or tension myalgias, this condition is characterized by a chronic fatigue, with widespread pain in a patient’s muscles, ligaments, and tendons. In 1990, the American College of Rheumatology defined the criteria for fibromyalgia as the chronic presence of pain under pressure in 11 of 18 identified sites, such as the upper back, upper chest, back of head, neck, elbows, hips, and knees, among others. Additionally, a variety of other symptoms often accompany FMS. These may include sleep disruptions (leg muscle spasms, restless leg syndrome or bursts of conscious-level brain activity), irritable bowel syndrome, chronic headaches, facial pain, and heightened sensitivity to various stimuli. Notably, one-third of fibromyalgia sufferers report depression, and temporomandibular joint dysfunction (TMJ) is also a very common complaint. Numbness or tingling in the limbs, dizziness, painful menstrual periods, chest or pelvic pain, and dry skin, mouth and eyes are also typical symptoms. Treatment options are limited as there are no drugs specifically approved by the U.S. Food and Drug Administration for the treatment of FMS. Milnacipran (brand name Ixel), is currently being evaluated for treatment of the Fibromyalgia Syndrome (FMS). Milnacipran has shown to provide significant improvement of pain and fatigue symptoms in a preliminary analysis Phase II clinical trial. This trial was the first to evaluate Milnacipran as a potential treatment for FMS. The study evaluated the efficacy and safety of Milnacipran (Ixel) for the treatment of pain and associated symptoms such as fatigue, depressed mood and sleep. Patients were asked to characterize their pain, fatigue, sleep and related symptoms several times each day. Milnacipran treated patients randomized to the twice a day dosing group (BID) showed statistically significant improvements in pain compared to those who received placebo. In addition, Milnacipran treated patients showed significant improvements in fatigue and depressed mood. Treating the complex pain of FMS with existing medications has so far been met with limited success. Milnacipran, a novel dual-acting reuptake inhibitor that acts on two key neurotransmitters in the human body, appears to have the potential to relieve several of the symptoms associated with FMS. Eighty-four percent of all Milnacipran patients escalated to the highest dose with no tolerability issues. The most common dose-related side effect reported by patients from Milnacipran was nausea, particularly early in the study. Most adverse events from Milnacipran were mild to moderate in intensity. Milnacipran is currently approved to treat depression in 22 countries, including France and Japan. Approved Uses © IAS Ltd. | |
