Ongoing Savella Trials
Forest Laboratories, Inc. and Cypress Bioscience, Inc. have reported that patients treated with 50 mg. of Savella (milnacipran HCI) twice a day experience significant relief from pain, improved physical function, and demonstrate better patient global assessments. The results of the latest large-scale, Phase III clinical trial produced significant positive statistics and proved general clinical improvement. The study was presented on October 20, 2009, at the American College of Rheumatology Annual Meeting in Philadelphia. Doctors have found that 100 mg. of Savella daily, is the most effective dosage for the selective serotonin and norepinephrine dual reuptake inhibitor (SNRI). The drug received approval from the USFDA only this year, for managing the symptoms of fibromyalgia.
Fibromyalgia syndrome expresses itself as a chronic ailment with its main symptom widespread joint and muscle pain. As many as six million US citizens suffer from the debilitating effects of fibromyalgia. The newest trial shows that those patients treated with Savella were much improved compared to those treated with the placebo. The results were measured through the analysis of patient reports on a composite responder. The newest results echo the earlier positive results regarding the effectiveness and safety of Savella at this dose and at a higher dose of 200 mg. daily.
Lead investigator for the study, Lesley M. Arnold, MD, a professor of psychiatry at the University of Cincinnati College of Medicine commented, "Fibromyalgia is a common, chronic pain disorder that can be associated with an array of debilitating symptoms, so it is important that treatments manage the multiple symptoms of fibromyalgia and improve function."
The object of this Phase III, double-blind, placebo-controlled trial including 1,025 fibromyalgia sufferers was to determine whether earlier positive results could be repeated regarding the efficiency and patient tolerability of Savella at 100 mg. a day. Patients were given Savella or the placebo on a random basis, receiving treatment with one or the other for 4-6 weeks during which the dose was slowly escalated. Then the subjects were administered a stable dose of either Savella or the placebo for a further 12 weeks. This was followed by a randomized, 2 week, double-blind phase of gradual cessation of treatment.
During the course of the clinical trial, the patients cooperated in measuring the results of their treatment through the use of visual analog scale for pain, patient global assessment through which the patient gives his impression of changes brought on by treatment, and the Short Form-36 Physical Component Summary, through which patients can describe physical function. More patients on the Savella treatment for three months, as opposed to the placebo, reported a minimum of a 30% improvement, stating they were either "much improved," or "very much improved," in relation to patient global assessment and in reduction of pain. Some patients experienced significant reduction in pain after one week of treatment on the stable dose of Savella.
Forest Research Institute's president, Dr. Marco Taglietti, commented, "These data confirm the benefits of Savella in managing fibromyalgia. Patients receiving Savella showed simultaneous improvements on multiple measures of fibromyalgia, including pain, patient global assessment, and physical function."