Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved the antidepressant Cymbalta (duloxetine HCl) for the treatment of generalized anxiety disorder (GAD), a condition that affects more than 6.5 million American adults in a given year.
Because GAD presents with a variety of symptoms, it can be difficult to diagnose and may have a negative impact on a person's ability to function properly in work, family and social situations.
The safety and efficacy of Cymbalta in the treatment of GAD was established in three randomized, double-blind, placebo-controlled studies in more than 800 non-depressed adults with GAD. In all studies, Cymbalta significantly improved core anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA), compared with placebo. In addition, Cymbalta patients reported greater improvement in functional impairment associated with the illness, including improved ability to perform everyday activities at work, home, and in social situations.
"If left untreated, symptoms of generalized anxiety disorder may worsen, potentially impacting many aspects of a person's life, including their job and social relationships," said Susan Kornstein, M.D., professor of psychiatry at Virginia Commonwealth University. "With this approval, physicians and patients will be happy to know that there is another medication now available to treat this debilitating condition."
Cymbalta, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitor (SNRI), has been studied in more than 25,000 patients worldwide and is already approved for the treatment of major depressive disorder and management of diabetic peripheral neuropathic pain, both in adults.
"More than 4.5 million adults in the United States have been prescribed Cymbalta for major depressive disorder or diabetic peripheral neuropathic pain," said Mike Detke, M.D., Ph.D, Cymbalta medical director for Eli Lilly and Company. "We are excited to offer a new, approved treatment option for generalized anxiety disorder patients and are eager to continue our research with this medication."