FDA OKs Fibromyalgia Drug Savella
Savella Joins Cymbalta and Lyrica as Drugs Approved for
Fibromyalgia Patients
Jan. 15, 2009 -- The FDA has approved a new drug called Savella for the
management of fibromyalgia.
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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