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PR Newswire Europe - U.S. Regulators Approve Cymbalta(R) for Treatment of Generalised Anxiety Disorder.

admin — Sun, 04 Jan 2009 08:16:01 +0000

INDIANAPOLIS, February 26 /PRNewswire/ —
The U.S. Food and Drug Administration (FDA) has approved the antidepressant Cymbalta(R) (duloxetine HCl) for the treatment of generalised anxiety disorder (GAD), Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim announced today.

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The approval is based on the results of three randomized, double-blind, placebo-controlled studies in which the safety and efficacy of duloxetine in the treatment of GAD was studied in more than 800 non-depressed adults. In all studies, duloxetine significantly improved core anxiety symptoms as measured …

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Market Wire - New Study Suggests Cymbalta(R) Reduced Depression Symptoms at Least as Fast as a Leading Competitor

admin — Wed, 31 Dec 2008 23:11:02 +0000

Cymbalta (duloxetine hydrochloride)
reduced symptoms of depression at least as fast as Lexapro
(escitalopram) by the end of two weeks, according to results from the first
head-to-head study comparing the two antidepressants. The results were
released by Eli Lilly and Company (NYSE: LLY) at a meeting of a major
scientific society.

In this eight-week study, Cymbalta, a serotonin and norepinephrine reuptake
inhibitor, was effective in reducing depression symptoms (defined as onset
of efficacy) by two weeks for 42 percent of patients. Within the same time
period, 35 percent of patients taking Lexapro, a selective serotonin
reuptake inhibitor, and 22 percent of patients who received a sugar pill
had 20 percent reduction of symptoms. While not indicative of faster onset
of action than Lexapro in patients with major depressive disorder, this
study showed Cymbalta’s onset to be at least as fast as that of Lexapro.

While Cymbalta was significantly better than sugar pill at reducing
depression symptoms, Lexapro was not in this study. In other studies
Lexapro has shown significant improvement versus sugar pill in reducing
depression symptoms.

“Previous data has shown that Cymbalta may work as early as one week. In
this study Cymbalta works at least as fast as Lexapro,” says John Greist,
M.D., clinical professor of psychiatry, University of Wisconsin Medical
School.

“This study was the first to compare Cymbalta with Lexapro, and the first
to measure onset of efficacy of Cymbalta as compared to an SSRI,” says
Madelaine Wohlreich, M.D., medical advisor for Eli Lilly and Company.

Additional study highlights

– The percentages of patients who responded to treatment with Cymbalta,
Lexapro or sugar pill (48.7 percent, 45.3 percent and 36.9 percent,
respectively) were statistically no different.
– Percentage of patients achieving remission on Cymbalta, Lexapro or
sugar pill (40.1 percent, 33.0 percent and 27.7 percent, respectively) were
statistically no different in this study.
– Cymbalta and Lexapro both had statistically significant changes in the
Clinical Global Impression of Severity (CGI-S) scale and the self-reported
Patient Global Impression of Improvement (PGI-I) scale, when compared with
sugar pill.
– Patients taking Cymbalta experienced more side effects, including
nausea and dry mouth, compared with those taking Lexapro and sugar pill,
but the rates at which patients dropped out of the study because of side
effects were statistically no different (7.3 percent for Cymbalta, 5.1
percent for Lexapro and 5.8 percent for sugar pill).

Methods

A total of 684 patients with major depressive disorder aged 18 years and
older participated in the eight-week, multi-center, double-blind,
placebo-controlled clinical trial, conducted entirely within the United
States from November 2003 to May 2005. The patients were randomized to
receive either 60 mg of Cymbalta once daily (n=273), 10 mg of Lexapro once
daily (n=274), or a sugar pill once daily (n=137).

Onset of efficacy was defined as at least a 20 percent decrease from
baseline in the Maier subscale of the Hamilton Depression Scale (HAM-D17)
that was maintained at each visit. Secondary measures included the
Hamilton Anxiety Ratings Scale (HAMA), CGI-S and PGI-I. Standard safety
measures were also collected.

This is the only study that has compared Cymbalta and Lexapro. The study
compared Cymbalta at its highest approved dose of 60 mg per day to
Lexapro’s lowest approved dose of 10 mg per day, however those doses
represent the recommended therapeutic doses of each medication and are
widely used.

About Depression

Up to 19 million Americans have depressive disorders, including major
depression.(i) It can happen to anyone of any age, race or ethnic group,
however women are nearly twice as likely to experience depression as
men.(ii) Although it is one of the most frequently seen psychiatric
disorders in the primary care setting, it often goes undiagnosed, or is
under-treated.(iii) This may be because depressed patients often present
physical symptoms rather than emotional complaints. In one study, nearly
70 percent of patients diagnosed with depression reported physical symptoms
as their chief reason for seeking help.(iv)

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to
both mediate core depression symptoms and help regulate the perception of
pain. Disturbances of serotonin and/or norepinephrine may explain the
presence of both the emotional and physical symptoms of depression. Based
on pre-clinical studies, duloxetine is a balanced and potent reuptake
inhibitor of serotonin and norepinephrine. While the mechanism of action
of duloxetine is not fully known, scientists believe its effect on both
emotional symptoms and pain perception is 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 and the management of diabetic peripheral neuropathic
pain, both in adults. Cymbalta is not approved for use in pediatric
patients.

Clinical Psychiatry News - Lilly warned on Cymbalta

admin — Sun, 28 Dec 2008 22:16:02 +0000

A promotional brochure mailed to physicians on Cymbalta (duloxetine) delayed-release capsules overstates the drug’s efficacy and “omits some of the most serious and important risk information associated with its use,” said the Food and Drug Administration in a late September warning letter sent to the drug’s maker, Eli Lilly & Co.

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The agency questioned the references used to support the efficacy claims, and also said that even though the brochure included information from the boxed warning, it did not include contraindications in uncontrolled narrow-angle glaucoma and with monoamine oxidase inhibitors.
COPYRIGHT 2007 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Chain Drug Review - Cymbalta contract

admin — Sat, 27 Dec 2008 16:11:03 +0000

Eli Lilly and Co. and Boehringer Ingelheim GmbH have agreed to commercialize Cymbalta for the treatment of depression in countries outside the United States (excluding Japan). Lilly anticipates that it will make a European submission for the product this year.

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Chain Drug Review - Cymbalta found safe as nerve pain treatment

admin — Sat, 20 Dec 2008 21:46:02 +0000

Cymbalta has been found safe and well-tolerated as a drug treatment for diabetic nerve pain. The study in the Journal of Palliative Medicine also concludes that the Eli Lilly & Co. product does not adversely affect the progression of diabetes or such complications as damage to the nerves, kidneys and eyes.

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Philadelphia Inquirer, The - Wyeth says heart–drug competition was surprise

admin — Tue, 16 Dec 2008 03:36:04 +0000

THE FDA SAYS development of a potentially life-threatening serotonin syndrome may occur in treatment with four selective serotonin reuptake inhibitors: Lilly’s Cymbalta (duloxetine HCl) delayed release capsules, Wyeth’s Effexor (venlafaxine HCL) tablets and Effexor extended release capsules, Lilly’s Prozac (fluoxetine capsules and oral solution) and Lilly’s Symbyax (olanzapine and fluoxetine HCL capsules).

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-JGD
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Provided by ProQuest Information and Learning Company. All rights Reserved

Market Wire - New Data Suggest Cymbalta(R) Reduced Pain in Fibromyalgia Patients With and Without Depression

admin — Tue, 09 Dec 2008 13:06:02 +0000

New data suggest that patients with
fibromyalgia treated with 60mg or 120mg of Cymbalta (duloxetine HCl)
experienced greater reduction in pain severity beginning one week after
starting duloxetine than those taking placebo (sugar pill), as measured by
the Brief Pain Inventory Average Pain Score (BPI). The study, which
included patients with and without depression, also showed greater
improvements in patients taking duloxetine than in those taking placebo in
scores on the Patient’s Global Impression of Improvement questionnaire
(PGI-I), which measures how the patient has felt overall since beginning to
take the medication. The data were presented today at the 2007 Congress of
the International MYOPAIN Society in Washington, D.C.

At three months, patients treated with 60mg per day or 120mg per day of
duloxetine showed significantly greater reduction in pain and improvement
in PGI-I scores compared with patients taking placebo. At three months,
more patients treated with either 60mg or 120mg of duloxetine showed
significantly greater reduction in pain as measured by a 30 percent
improvement in baseline BPI scores (50.7 percent and 52.1 percent,
respectively) compared with patients taking placebo (36 percent).

“Fibromyalgia is a chronic illness, characterized by widespread pain,
tenderness and fatigue. It can also affect the patient’s overall emotional
health and well-being,” said I. Jon Russell, M.D., Ph.D., associate
professor of medicine at the University of Texas Health Science Center in
San Antonio. “Between 34 percent(1) and 62 percent(2) of those living with
fibromyalgia will experience depression at some point in their lives. In
this study, which included patients with and without depression, duloxetine
reduced the pain associated with fibromyalgia.”

Fibromyalgia is estimated to affect 2 percent to 4 percent of the U.S.
population(3), the majority being women. In addition to chronic pain,
fibromyalgia patients often have complaints about cloudy thinking, morning
stiffness and overall inability to function in their everyday lives.

Additional Study Highlights

– At six months, patients taking duloxetine 60mg or 120mg maintained
reduced BPI scores and patients taking 120mg had improved PGI-I scores
compared with those taking placebo.

– At the end of the six-month trial, more patients treated with both
60mg or 120mg of duloxetine showed a response to treatment, defined as a 50
percent reduction of baseline BPI scores (32.6 percent and 35.9 percent of
patients, respectively), compared with patients taking placebo (21.6
percent).

– Discontinuation rates over six months were similar among the groups
(45.3 percent and 46.3 percent for duloxetine 60mg and 120mg patients,
compared with 50 percent for placebo).

— Adverse event-related discontinuation was significantly higher in
patients taking 120mg (26.5 percent) but not in the 60mg (15.3 percent)
group as compared with placebo (13.2 percent). Discontinuations due to
lack of efficacy were not statistically different among treatment
groups.

— Adverse events were similar to those seen in prior duloxetine studies.
In this study, the most common adverse events (occurred at a rate of
greater than or equal to 5 percent and at least twice the rate of
placebo) included nausea, dry mouth, constipation, somnolence
(sleepiness), fatigue, insomnia, decreased appetite, hyperhydrosis,
cough, tremor, rash and weight increase.

Fibromyalgia sNDA Submitted to FDA

Eli Lilly and Company (NYSE: LLY) also announced today that it recently
submitted a supplemental new drug application (sNDA) to the U.S. Food and
Drug Administration (FDA) for Cymbalta for the management of fibromyalgia.
The sNDA submission is based on data from approximately 1,400 patients in
five clinical trials.

“Lack of awareness of fibromyalgia can lead to frustration as patients
often see multiple physicians over a number of years before receiving a
formal diagnosis,” said Alan Breier, M.D., vice president for medical and
chief medical officer, Eli Lilly and Company. “This research may help
increase recognition of fibromyalgia and offer hope to those living with
this debilitating condition.”

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 (MDD), the management of diabetic peripheral
neuropathic pain (DPNP) and the treatment of generalized anxiety disorder
(GAD), all in adults (age 18). Cymbalta is not approved for use in
pediatric patients.

PR Newswire - Patients Taking Cymbalta® Reported Reduced Pain Severity of Osteoarthritis of the Knee in New Study

admin — Sat, 06 Dec 2008 21:01:03 +0000

Patients on Treatment Also Experienced Improved Physical Functioning
INDIANAPOLIS, June 13 /PRNewswire-FirstCall/ — New data suggest that patients with osteoarthritis pain of the knee treated with 60 mg and 120 mg Cymbalta (duloxetine HCl) once daily experienced significant pain reduction. Patients taking duloxetine reported significant pain improvement compared to placebo within the first week of treatment that lasted throughout the 13-week trial.(1) Results from the study of 231 patients were presented today at the annual congress of the European League Against Rheumatism (EULAR) in Paris, France.
Duloxetine showed statistically significant improvement in pain associated with osteoarthritis of the knee according to the primary efficacy measure of mean 24-hour average pain scores. Fifty-nine percent of duloxetine-treated patients experienced a 30 percent improvement in pain compared with 45 percent of patients taking placebo. Forty-seven percent of duloxetine-treated patients experienced a 50 percent improvement in pain compared with 29 percent of placebo-treated patients.
Treatment with duloxetine also was associated with improved patient outcomes compared with placebo as measured by the Patient Global Impressions of Improvement (PGI-I) and physical functioning as measured by the Western Ontario and McMaster Universities (WOMAC) physical functioning subscale.
In this study, the most common adverse events (occurred at a rate of greater than or equal to 3 percent and at least twice the rate of placebo) were nausea, fatigue, somnolence, dizziness, hypertension, constipation and decreased libido.
“These data are important because it’s the first time duloxetine has been studied in a large, placebo-controlled trial in what’s classified as an inflammatory disease state,” said Amy Chappell, M.D., lead study author and medical fellow II, Eli Lilly and Company. “Although the exact mechanism of action is unknown, this study may provide important insights into the treatment of pain in the central nervous system.”
It is estimated that 27 million adults in the United States have osteoarthritis and the prevalence increases with age.(2) Osteoarthritis of the knee is a common type of this disorder, impacting the lives of approximately 10 million Americans.(2) Other symptoms of osteoarthritis in addition to pain include aching, stiffness and limited range of motion of the joint.(3)
Additional Study Highlights:
- Compared with patients receiving placebo, patients receiving duloxetine
experienced significant improvement in symptom severity associated with
osteoarthritis pain of the knee, including:
* Significantly greater reduction in Brief Pain Inventory (BPI)
average pain severity (p

Medical Marketing and Media - ELI LILLY AND CO. HELD

admin — Tue, 02 Dec 2008 19:46:02 +0000

ELI LILLY AND CO. HELD its 10th Annual Welcome Back Awards May 3 in Washington, DC. The awards honor individuals for outstanding commitments to mental health. Through them, Lilly has donated nearly $500,000 to nonprofits. This year’s winners included Rory White (at right), founding manager of LA’s Skid Row Lamp Art Project, who was named Welcome Back Awards Person of the Decade.

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Lilly, which markets Cymbalta, founded the awards to fight the stigma associated with depression and promote understanding that it’s treatable. -Matthew Arnold
Copyright Haymarket Media, Inc. Jun 2008
Provided by ProQuest Information and Learning Company. All rights Reserved

Harvard Mental Health Letter - Questions & Answers.

admin — Mon, 01 Dec 2008 15:56:02 +0000

Q. Does the new antidepressant duloxetine (Cymbalta) have any advantages over other antidepressant drugs?
A. Duloxetine (Cymbalta) became available by prescription in the summer of 2004. Described as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), it boosts the activity of two neurotransmitters that play a role in depression.

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Dual-action medications already available include older tricyclic antidepressants and two more recent drugs, venlafaxine (Effexor) and mirtazapine (Remeron). Especially for patients with moderate to severe depression, dual-action drugs may work better than the popular antidepressants that …
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