FDA Approves Generic Duloxetine for Fibromyalgia-associated Pain and Depression
The U.S. Food and Drug Administration has approved Duloxetine, a generic version of Cymbalta (duloxetine), for treating fibromyalgia, depression, and anxiety, according to the generic’s maker, Solco Healthcare U.S.
In addition to fibromyalgia, Duloxetine, the active ingredient in Cymbalta, is used to treat serious depression in adults, and anxiety in adults and children 7 years and older.
Scientists say Duloxetine works by increasing levels of the neurotransmitters serotonin and noradrenaline in the nervous system.
“We are pleased to receive this FDA approval, which adds to our growing line of central nervous system acting agents,” Hai Wang, president of Solco Healthcare, said in a press release. “We continue to strengthen our presence within the U.S. generic market by providing high-quality medicines at affordable prices.”
Time-released Duloxetine capsules are available in three formulations: 20, 30 and 60 mg.
Hallmarks of fibromyalgia include chronic musculoskeletal pain, extreme fatigue, and sleep and mood disturbances. Patients can also experience psychological distress, including depression and anxiety. They often use antidepressants to help cope with these problems.
Previous studies have shown that duloxetine benefits fibromyalgia patients.
In a clinical trial, researchers at the University of Turin in Italy compared duloxetine’s benefits in fibromyalgia patients with those of the depression treatment acetyl L-carnitine.
Both duloxetine and acetyl L-carnitine reduced depression and pain, and improved patients’ physical quality of life. But only duloxetine improved patients’ psychological quality of life.
A Phase 3 clinical trial in Japan (NCT01552057) assessed duloxetine’s safety and effectiveness in 393 people with fibromyalgia. The patients were randomly assigned to receive either duloxetine or a placebo once a day for 14 weeks.
Duloxetine did a significantly better job than a placebo in relieving fibromyalgia patients’ pain and improving both their other symptoms and quality of life. It was also safe, and patients tolerated it well.
Fibromyalgia affects an estimated 5 million to 15 million Americans, especially women. Experts say there is a pressing need for therapies to address the many facets of the disease.