Fibromyalia Patients Have New Drug For Pain Relief
The FDA approved milnacipran (Savella) for fibromyalgia pain treatment on January 14, 2009. Milnacipran is a selective norepinephrine and serotonin reuptake inhibitor.
The drug was originally developed and manufactured by Pierre Fabre Medicament in France. It was approved in that country as an antidepressant in 1997. Cypress Bioscience and Forest Laboratories partnered with Pierre Fabre in the development of milnacipran for the treatment of fibromyalgia (FM) in the United States.
The approval was made on the basis of two Phase 3 efficacy trials. Both studies were randomized, double-blind, placebo-controlled trials that enrolled subjects 18 to 70 years of age with a diagnosis of fibromyalgia. All subjects were diagnosed using the American College of Rheumatology criteria. They showed that doses of 100 mg/day and 200 mg/day caused significant improvement in pain and physical function.
Forest Laboratories and Cypress Bioscience expect the drug to be available by March. The drug is not approved for use in children, and should not be used in patients taking monoamine oxidase inhibitors or in those with uncontrolled narrow-angle glaucoma, the drug makers said.
The drug's label includes a boxed warning for increased risk of suicidal ideation, thinking, and behavior in children, adolescents, and young adults who are taking antidepressants for major depressive disorder or other psychiatric disorders.
The most common adverse reactions were nausea, constipation, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, and hypertension.
Fibromyalgia (FM) is a chronic condition characterized by diffuse musculoskeletal pain, fatigue and disordered sleep. It is also frequently associated with depression and other psychiatric conditions, cognitive difficulties and headaches. It primarily affects women between the ages of 30 and 50, but can also be seen in younger and older women, and in men. There are two other recently approved products for the management of FM, Lyrica and Cymbalta.
Drugs @ FDA