Eli Lilly and Company (NYSE: LLY)
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(1). Because GAD presents with a
variety of symptoms, it can be difficult to diagnose(2) and may have a
negative impact on a person's ability to function properly in work, family
and social situations(3).
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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)(4), 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."
In clinical trials, on average, patients treated with Cymbalta for
generalized anxiety disorder experienced a 46 percent improvement in
anxiety symptoms compared to 32 percent for those who took placebo, as
measured by the Hamilton Anxiety Scale. In addition, patients in these
studies experienced a 46 percent improvement in function compared to 26
percent for those who took placebo as measured by the Sheehan Disability
Scale. The most common side effects in these studies included nausea,
fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite,
hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile
dysfunction. In clinical trials, Cymbalta was studied in a dose range of
60-120 mg per day. While a 120mg/day dose was shown to be effective, there
is no evidence that doses greater than 60mg/day confer additional benefit.
Cymbalta comes in a capsule, and the target daily dose is 60 mg.
About Generalized Anxiety Disorder
Approximately 6.5 million Americans are diagnosed with generalized anxiety
disorder each year(5). Symptoms persist for at least six months and can
include exaggerated worry or chronic anxiety, irritability, poor
concentration, sleep disturbance and fatigue(6) (7). Generalized anxiety
disorder may be brought on, or worsened by, stressful life events. The
illness also tends to be chronic with periods of exacerbation and
remission(8).
About Cymbalta
Serotonin and norepinephrine in the brain and spinal cord are believed to
both mediate core mood symptoms and help regulate the perception of pain.
Based on pre-clinical studies, duloxetine is a balanced and potent reuptake
inhibitor of serotonin and norepinephrine that is believed to potentiate
the activity of these chemicals in the central nervous system (brain and
spinal cord). While the mechanism of action of duloxetine is not fully
known, scientists believe its effects on depression and anxiety symptoms,
as well as its effect on pain perception may be due to increasing the
activity of serotonin and norepinephrine in the central nervous system.
Cymbalta is approved in the United States for the treatment of major
depressive disorder, the management of diabetic peripheral neuropathic pain
and now the treatment of generalized anxiety disorder, all in adults.
Cymbalta is not approved for use in pediatric patients.
Important Safety Information
Cymbalta is approved to treat major depressive disorder, diabetic
peripheral neuropathic pain and generalized anxiety disorder. In children
and teens, antidepressants can increase the risk of suicidal thoughts or
actions. Patients should call their doctor right away if they experience
worsening depression symptoms, unusual changes in behavior or thoughts of
suicide, especially at the beginning of treatment or after a change in
dose. Cymbalta is approved only for adults 18 and over.
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