MedPage Today reports that the FDA has approved duloxetine (Cymbalta), an SNRI (serotonin-norepinphrine reuptake inhibitor), for fibromyalgia (FMS).
This is only the second drug to be approved for FMS. Last year the the FDA approved the anti-seizure drug pregabalin (Lyrica) for FMS.
This story is huge for those suffering from FMS. Particularly because, my anecdotal observation is that Cymbalta is much better tolerated in patients than Lyrica. Unfortunately, Cymbalta costs about 70% more than Lyrica.
There have been two placebo-controlled clinical trials of Cymbalta in 874 patients with FMS – each showing a 30% reduction in pain. Even more importantly, the pain relief was seen during the first week of treatment.
In addition, 65% – 66% of the patients on Cymbalta felt better once beginning treatment with Cymbalta 60 mg a day.
Nevertheless, one in five patients had to discontinue the drug due to side effects such as nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation.