“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.”
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.