NEW YORK -- June 16, 2008 -- The US Food and Drug Administration (FDA) has approved duloxetine HCl (Cymbalta) for the management of fibromyalgia, a chronic widespread pain disorder. Duloxetine HCl is a serotonin-norepinephrine reuptake inhibitor indicated to reduce pain in patients with fibromyalgia.
Duloxetine HCl was proven efficacious in 3 pivotal 3-month clinical trials involving 874 patients with fibromyalgia. In both studies, duloxetine HCl reduced pain at the study's endpoint compared with placebo as measured by the Brief Pain Inventory (BPI) 24-hour average pain scale.
Significant improvement in pain for duloxetine HCl versus placebo was observed in the first week of each study. Fifty-one percent and 55% of patients on duloxetine HCl had a 30% improvement on the BPI at the study's endpoint. In addition, 65% and 66% of patients taking duloxetine HCl 60 mg daily reported feeling better at the study's endpoint as measured by the Patient Global Impression of Improvement (PGI-I). Duloxetine HCl 60 mg was also superior to placebo on the Fibromyalgia Impact Questionnaire Total Score.
In 4 pooled studies, the most commonly observed adverse events in duloxetine HCl-treated patients with fibromyalgia were nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation. In the placebo-controlled clinical trials, the overall discontinuation rates due to adverse events for duloxetine HCl versus placebo were 20% and 12%, respectively.
The approval marks the fourth disorder that the FDA has approved for duloxetine HCl. In addition to fibromyalgia, duloxetine HCl is approved for the management of diabetic peripheral neuropathic pain (DPNP) and the treatment of major depressive disorder and generalised anxiety disorder, all in adults aged 18 years and older.
SOURCE: Chamberlain Healthcare Public Relations
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