Posted by MERM on 1/21/2009, 11:56 am
FDA Approval of Savella for the Management of Fibromyalgia
On January 14th the Forest and Cypress have announced that the U.S. Food and Drug Administration (FDA) have approved Savella (also known as milnacipran) for the management of fibromyalgia.
From the press release:
"The safety and efficacy of Savella was established in two US pivotal phase III clinical trials involving over 2,000 patients with fibromyalgia. The studies showed that Savella doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function. The companies expect Savella to be available in (U.S.) pharmacies by March 2009."
Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan. said "Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia. The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis.
Savella Joins Cymbalta and Lyrica as Drugs Approved for Fibromyalgia Patients
Savella belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs), which include some antidepressants.
The drug companies behind Savella -- Forest Laboratories Inc. and Cypress Bioscience Inc. -- report that the FDA approved Savella based on two clinical trials that together included 2,084 fibromyalgia patients who took Savella or a placebo for three months or six months.
Savella trumped the placebo in the percentage of patients of who reported at least a 30% reduction in pain and also rated themselves as being "very much improved" or "much improved" in terms of their fibromyalgia, according to a joint news release from Forest Laboratories and Cypress Biosciences.
Savella was safe and generally well tolerated, according to Forest Laboratories and Cypress Biosciences. The drug companies report that nausea was the most common side effect in the clinical trials and that other commonly reported adverse reactions were constipation, hot flush, sweating, vomiting, palpitations, increased heart rate, dry mouth, and hypertension (high blood pressure).
Savella, which is expected to be available by prescription in March, is only approved for adults. It will bear the same "black box" warning as antidepressants about increased risk of suicidal thinking and behavior in children, adolescents, and young adults.
Savella will get a medication guide outlining its risks. And the FDA is requiring postmarketing studies of the pregnancy and fetal outcomes in women who take Savella while pregnant, and a clinical trial of Savella's effects on babies exposed to the drug from breastfeeding.
Other FDA-approved fibromyalgia drugs include the nerve pain drug Lyrica and the SNRI antidepressant Cymbalta. Other antidepressants may be used to treat fibromyalgia but aren't specifically approved by the FDA for that use.
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