FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
INDIANAPOLIS, Nov. 30 /PRNewswire-FirstCall/ -- Eli Lilly and Company
(NYSE: LLY) announced today that the U.S. Food and Drug Administration
(FDA) has approved Cymbalta(R) (duloxetine HCl) for the maintenance
treatment of major depressive disorder (MDD) in adults.
"Relapse, the re-emergence of depressive symptoms after a successful
treatment of depression, is a significant clinical concern," says Doug
Williamson, M.D., Cymbalta associate medical director for Eli Lilly and
Company. "This approval from the FDA is important because data from our
Cymbalta clinical trial demonstrate that continuing to treat the patient
delays the time to possible relapse."
Treating the broad range of depression symptoms may minimize the
presence of residual symptoms (e.g., anxiety, guilt and low self-esteem)
and can help delay the time to relapse(1). Common symptoms of depression
can include sadness, loss of interest, fatigue, changes in appetite or
weight, or bodily aches and pains.
"Once an episode of depression has been successfully treated, it is
imperative that the symptoms do not return," said Lauren Marangell, M.D.,
an internationally recognized expert on depression and other mood disorders
and a distinguished scholar at Lilly. "The American Psychiatric Association
has recommended maintenance of antidepressant treatment to help decrease
the chance of relapse."
The efficacy and safety of Cymbalta for maintenance treatment of major
depression was established in a double-blind, placebo-controlled clinical
trial. Patients with major depression in the trial (533 patients) received
Cymbalta 60 mg once daily. After 12 weeks, 278 patients met the criteria
for entering the continuation phase and were randomly assigned to either
Cymbalta at the same dose or to a sugar pill for 6 months. Patients on
Cymbalta experienced a statistically longer time to relapse of depression
than did patients on placebo. Relapse was defined as an increase of two or
more points on the Clinical Global Impression - Severity scale (CGI-S)
compared with that obtained at week 12, and also meeting the criteria for
major depressive disorder for two consecutive visits.
In this study, nausea was the most frequently reported side effect
(also referred to as a treatment-emergent adverse event) during the acute
phase and was reported as a reason for discontinuation for 2.1 percent of
patients. In the continuation phase, there were no significant differences
in reported side effects between patients taking Cymbalta compared with
those taking sugar pills. Among patients who completed the first 12 weeks
of the trial and entered the continuation phase, 3.6 percent reported side
effects as reasons for discontinuation over the next 26 weeks (continuation
phase) of the study.(2)
Cymbalta, a member of a class of drugs commonly referred to as
serotonin and norepinephrine reuptake inhibitors (SNRI), has been studied
in more than 27,000 patients worldwide. Cymbalta is already approved for
the acute treatment of major depressive disorder, the management of
diabetic peripheral neuropathic pain, and for the treatment of generalized
anxiety disorder, all in adults. More than 9 million adults in the United
States have been prescribed Cymbalta since approval.
About Cymbalta
Serotonin and norepinephrine in the brain and spinal cord are believed
to both mediate mood symptoms of depression 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.
Important Safety Information
Cymbalta is approved to treat major depressive disorder and generalized
anxiety disorder and manage diabetic peripheral neuropathic pain.
Antidepressants can increase suicidal thoughts and behaviors in children,
adolescents and young adults. Patients should call their doctor right away
if they experience new or worsening depression symptoms, unusual changes in
behavior, or thoughts of suicide. Be especially observant within the first
few months of treatment or after a change in dose. Cymbalta is approved
only for adults 18 and over.
Cymbalta is not for everyone. Patients should not take Cymbalta if they
have recently taken a type of antidepressant called a monoamine oxidase
inhibitor (MAOI), are taking Mellaril(R) (thioridazine) or have
uncontrolled glaucoma. Patients should speak with their doctor about any
medical conditions they may have, including liver or kidney problems or
glaucoma. Patients should tell their doctor about all of their medicines,
including those for migraine to avoid a potentially life-threatening
condition, and NSAIDs, aspirin or blood thinners due to an increased risk
of bleeding. They also should talk to their doctor about their alcohol
consumption. Patients should consult with their doctor before stopping
Cymbalta or changing the dose and if they are pregnant or nursing.
Patients taking Cymbalta may experience dizziness or fainting upon
standing. The most common side effects of Cymbalta include nausea, dry
mouth, sleepiness and constipation. This is not a complete list of side
effects.
For full Patient Information, visit http://www.cymbalta.com.
For full Prescribing Information, including Boxed Warning, visit
http://www.cymbalta.com/.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs.
Additional information about Lilly is available at http://www.lilly.com.
P-LLY
This press release contains forward-looking statements about the
potential of Cymbalta for the maintenance treatment of major depressive
disorder, and reflects Lilly's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and uncertainties in
the process of development and commercialization. There is no guarantee
that the product will continue to be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's filings
with the United States Securities and Exchange Commission. Lilly undertakes
no duty to update forward-looking statements.
(1) Nierenberg, A. Long-Term Management of Chronic Depression. J Clin
Psychiatry 2001; 62 (Suppl 6):17-20.
(2) Perahia DG, et al. 2006. Duloxetine in the prevention of relapse of
major depressive disorder: double-blind placebo-controlled study. Br
J Psychiatry 188:346-353.
SOURCE Eli Lilly and Company
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