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 Aug 4 2004, 10:37 PM
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Gold Member
Group: Gold Member
Posts: 1,282
Joined: 21-July 04
From: USA
Member No.: 301
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a new one, hmmmm
FDA Approves New Antidepressant Drug
Wed Aug 4, 12:59 AM
WASHINGTON - The Food and Drug Administration approved sale of a new antidepressant for adults on Wednesday. Called Cymbalta, it should be on pharmacy shelves by late month.
Maker Eli Lilly & Co. is banking on Cymbalta as a successor to its once-blockbuster Prozac. Cymbalta, known chemically as duloxetine, is one of a newer class of antidepressants that targets two brain chemicals involved in depression, serotonin and norepinephrine.
It's the first antidepressant to hit the market since the FDA began investigating whether such drugs sometimes can increase the risk of suicide, particularly when used by teenagers, or if patients' underlying depression is to blame.
Cymbalta initially wasn't part of that still-ongoing debate. But it gained attention in February when a college student taking part in a study of the drug hanged herself in a company research facility. Lilly insists there's no evidence Cymbalta was to blame.
FDA closely scrutinized research on Cymbalta, looking at any suicides or suicidal behavior "on a case-by-case basis," and found no difference in the rate between users of the drug and those given a dummy pill, said Dr. Paul Andreason, the agency's primary reviewer.
But like all similar antidepressants, Cymbalta's label does bear a stern warning that doctors and families should closely watch patients for warning signs of suicide _ including agitation, anxiety or hostility _ especially when they first start the pills or change a dose.
Cymbalta is approved to treat major depression for up to nine weeks. In one study, Cymbalta users were almost three times as likely to achieve remission of their depression as patients given a dummy pill, said Lilly's Dr. Madelaine Wohlreich.
Cymbalta's average wholesale price will be $2.85 for 60 milligrams, the usual daily dose, which Lilly called comparable to similar competitors.
Lilly also is studying the drug as a possible treatment for stress urinary incontinence.
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Aug 6 2004, 03:47 PM
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Junior Member
Group: Junior Member
Posts: 89
Joined: 15-July 04
Member No.: 216
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Here's another article - this one's from the Lilly Newsroom. It does sound very similar to Effexor in terms of how it works. I wonder about the discontinuation syndrome, too, Katie.
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August 04, 2004
Dual-reuptake inhibitor judged safe and effective, giving doctors and patients a new option for treating the emotional and painful physical symptoms of depression
The U.S. Food and Drug Administration has approved Cymbalta® (duloxetine HCl; pronounced SIM-BALL-TA), judging it a safe and effective treatment for major depressive disorder, Eli Lilly and Company announced today.
Cymbalta, a balanced and potent reuptake inhibitor of serotonin and norepinephrine, has been studied in more than 6,000 adults with major depression worldwide. Its approval gives healthcare professionals and patients a long-awaited new option for treating the broad range of emotional and physical symptoms of depression. Today, only 25-35 percent of patients treated for depression in clinical studies experience relief from all of their disease symptoms.1
"Depression is a whole-body illness, but most modern antidepressants treat the emotional symptoms, such as crying and sadness, better than they treat the physical symptoms of depression," said Dr. Stephen Stahl, chairman of the Neuroscience Education Institute and adjunct professor of psychiatry at the University of California at San Diego School of Medicine. "Because of its dual action on serotonin and norepinephrine, Cymbalta offers physicians a new opportunity to help patients with depression, particularly those who experience the common physical symptoms of the disease, such as vague aches and pains."
Neurotransmitters are believed to help regulate a person's emotions and sensitivity to pain. Scientists believe that if these neurotransmitters are out of balance, a person may become depressed and be more likely to feel painful physical symptoms. The combination of emotional and painful physical effects of depression can have a tremendous negative impact on a person's quality of life.2
"Lilly's leadership in neuroscience and dedication to the treatment of depression is well established," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "Lilly is committed to solving the world's most pressing neuroscience problems, through research programs in Alzheimer's and Parkinson's as well as through our established expertise in depression, schizophrenia, bipolar disorder and Attention-Deficit/Hyperactivity Disorder."
Lilly demonstrated Cymbalta's effectiveness in treating major depression with data from four placebo-controlled clinical studies, all in adults. The safety and efficacy of Cymbalta in children have not been studied.
Milt Meyers, a participant in a Cymbalta clinical trial, found it worked for him. "Cymbalta worked for me," Meyers said. "I felt really good for the first time in a long time. I really felt like I was on the right track."
Cymbalta comes in a capsule and can be taken once a day. In clinical trials, Cymbalta was studied in a dose range of 40-120 mg per day. The recommended daily dose is 60 mg.
Duloxetine hydrochloride also is being studied for the treatment of stress urinary incontinence and diabetic neuropathic pain, conditions believed to respond to treatment with both serotonin and norepinephrine.
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Aug 7 2004, 11:52 PM
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Junior Member
Group: Junior Member
Posts: 73
Joined: 12-July 04
Member No.: 74
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QUOTE(Ocracoker16 @ Aug. 05 2004,11:32) Since this drug will be competing with Wyeth's Effexor which can be difficult to wean off, I would like to know how this drug in superior to Effexor in ease of discontinuation.
Katie:) Duloxetine has a short half life (15 hours I think? Something like that) like Effexor, so one can deduce that it will have some rough discontinuation effects. We'll see though. Maybe not. :confused:
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Aug 8 2004, 01:43 PM
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Forum Super Administrator
Group: Super Administrators
Posts: 13,302
Joined: 1-December 01
From: Sarasota, Florida
Member No.: 2
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Thank you for starting this topic, Hope12.. Interesting info for woman having a problem with incontinence : QUOTE Duloxetine significantly reduced the number of weekly incontinence episodes among women with stress urinary incontinence (SUI), according to a Phase III study published today in the Journal of Urology. Additionally, women on duloxetine experienced significant improvements in quality of life measures, when compared with women taking placebo.
SUI, a medical condition which affects approximately 30 million (1 in 3) American women over the age of 18(i), is attributable to a decreased urethral sphincter muscle function (at the bladder outlet), whereby accidental urine leakage results from an increase in abdominal pressure. This may be caused by normal actions such as laughing, coughing, sneezing, lifting or exercising. Once approved for use by regulatory agencies, duloxetine will become the first pharmaceutical treatment indicated to reduce the frequency of SUI episodes.
The Phase III data are consistent with previously published Phase II data and provide further support for duloxetine as a pharmacological agent for the treatment of SUI.
"These data are important for physicians and sufferers as there are currently no pharmaceutical options for the millions of women affected by SUI. A pharmaceutical option would be a welcomed choice," said Roger Dmochowski, MD, Professor of Urology in the Department of Urology at Vanderbilt University, Nashville, TN, and a principal investigator in this study.
Study Results
-- The results showed that duloxetine 80 mg, taken as 40 mg twice daily, significantly reduced the frequency of incontinence episodes by 50 percent versus 27 percent for placebo in women with SUI. Reduction of incontinent episodes is the medically recognized measurement of treatment efficacy.
-- Furthermore, 51 percent of all women taking duloxetine experienced a 50 percent to 100 percent reduction in frequency of incontinence episodes.
-- The improvements with duloxetine were not a result of more frequent voiding by the patients, in that the average time between voids (emptying of the bladder) was not decreased, but even increased overall by 20 minutes in the duloxetine group compared with 2 minutes in the placebo group
-- In addition, the significant duloxetine treatment response was unaffected by baseline incontinence severity (based on the number of incontinence episodes at the start of the study). Women experiencing 14 or more leakage episodes per week at baseline experienced a similar percentage reduction in their leakages as women experiencing fewer than 14 episodes per week at baseline.
-- The most commonly reported side effects with duloxetine in this study (incidence of greater than or equal to 10.0 percent and at least twice placebo) were: nausea, fatigue, dry mouth, insomnia, constipation and dizziness. After the first month of therapy, the incidence of these adverse events did not differ significantly between duloxetine- and placebo-treated patients.
Quality of Life Results
Of particular interest to many women, patients on duloxetine in this study also reported improvements on incontinence-specific scales used to measure effects on their quality of life. Patients taking duloxetine had significantly better improvements in their quality of life scores compared with patients taking placebo using a validated incontinence quality of life question survey. Based on the Patient Global Impression of Improvement (PGI-I) Scale, 62.0 percent of duloxetine-treated subjects rated their condition improved compared with 39.6 percent of placebo-treated women.
Study methodology
The Phase III double-blind placebo-controlled study performed in the United States and Canada enrolled a total of 683 women aged 22-84 years. All women had predominant SUI symptoms and experienced at least seven episodes of incontinence per week. Incontinence symptoms had to be present for a minimum of three months for a woman to be eligible for the study. The trial lasted 12 weeks. One primary measure of efficacy used by researchers was the incontinence episode frequency recorded by patients on real-time diaries. A second primary measure was the total score from the validated Incontinence Quality of Life (I-QOL) questionnaire. Additional measures included voluntary voiding frequency, the Patient Global Impression of Improvement (PGI-I) Scale and three I-QOL subscale scores.
About duloxetine
Duloxetine is a potent dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine. Duloxetine is believed to affect SUI by blocking the reuptake of serotonin and norepinephrine in the spinal cord, and the increase in the neurotransmitters in turn stimulates increased activity of the nerve that stimulates the urethral sphincter. This stimulation is believed to increase contraction of the urethral sphincter at the opening of the bladder, thereby helping prevent accidental urine leakage with physical activity.
The U.S. Food and Drug Administration recently issued an approvable letter for duloxetine for SUI.
About Stress Urinary Incontinence
SUI, with nearly twice the prevalence as urge incontinence, is the most common form of urinary incontinence among women. In the United States alone it affects approximately 30 million women over the age of 18(i). Although common, SUI is a medical condition that is not normal at any age, but unfortunately many women do not seek treatment because they are embarrassed, fear surgery, or believe it is a normal part of aging and that nothing can be done about it. Primary causes of SUI are nerve damage, muscle damage or weakness, and damage to the support of the bladder and urethra. Risk factors include childbirth, obesity, chronic coughing and constipation.
About Eli Lilly and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. Duloxetine is currently being developed for the treatment of stress urinary incontinence (SUI) and depression. This partnership covers most countries worldwide with few exceptions. In the USA, the collaboration focuses on SUI.
Links to Cymbalta News and Information:
Cymbalta® (duloxetine HCl)
cymbalta-pi.pdf
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--------------------
Be Well....
~Lindsay ♥, Forum Super Administrator
Founder, depressionforums.org
Forum Super AdministratorDF member since Dec 2001  ---- "I cannot make my mark for all time...those concepts are mutually exclusive.
"Lasting effect" is a self -contradictory term. Meaning does not exist in the future, nor do I.
Nothing will have meaning, "ultimately."
Nothing will even mean tomorrow what it did today. Meaning changes with the context.
My meaningfulness is in the here and now. It is enough that I may be of value to someone today.
It is enough that I make a difference now." ~Lindsay
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