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Duloxetine Application for Stress Urinary Incontinence Withdrawn From FDA Review

INDIANAPOLIS, Ind. and RIDGEFIELD, Conn., Jan 28, 2005 /PRNewswire-FirstCall via COMTEX/ -- Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc. today jointly announced that Lilly has withdrawn from the U.S. FDA's Division of Reproductive and Urologic Drug Products its New Drug Application for duloxetine hydrochloride for the treatment of stress urinary incontinence (SUI). This decision was based on discussions with the FDA suggesting the agency is not prepared at this time to grant approval for duloxetine for the treatment of the SUI patient population based on the data package submitted. The companies will evaluate all options for next steps once they have had time to fully understand the FDA's perspective. Ongoing clinical trials for duloxetine SUI will continue.

This action does not affect the marketing status of duloxetine for the indications of depression and diabetic peripheral neuropathic pain (DPNP) in the United States or the SUI and depression indications outside of the United States.

"Despite this decision, we continue to have confidence in duloxetine, which is currently available for the treatment of stress urinary incontinence in many other countries," said Sidney Taurel, chairman, president and chief executive officer, Eli Lilly and Company.

"We are certainly disappointed with this outcome but are committed to exploring our options for duloxetine, as millions of American women who suffer from SUI do not currently have a pharmaceutical option to help manage their condition," stated Dr. Alessandro Banchi, chairman of the Board of Managing Directors of Boehringer Ingelheim.

Duloxetine for the treatment of SUI, marketed as Yentreve® and AriClaim® outside of the United States, has been deemed safe and effective by regulatory authorities that have granted its approval in 27 countries throughout the world.

Duloxetine for the treatment of major depressive disorder and DPNP has already been approved by the U.S. FDA as a safe and effective treatment under the brand name Cymbalta®. The European Commission has approved duloxetine under the trade names of Cymbalta® and Xeristar® for major depressive episodes. Throughout the world, the drug is approved in 30 countries for major depression.

About SUI
SUI is the accidental leakage of urine during physical activities such as sneezing, coughing, laughing, lifting or exercising. It is an embarrassing and bothersome medical condition that affects nearly 15 million adult women in the United States(1,2) and can have a significant impact on quality of life. With nearly twice the prevalence of urge incontinence, SUI is the most common form of urinary incontinence among women.(3) Although common, it is a medical condition that is not normal at any age; unfortunately, many women do not seek treatment because they are embarrassed, fear surgery, or believe that it is a normal part of aging and that nothing can be done about it. The primary causes of SUI are weakness of the urethral sphincter and/or diminished pelvic support of the bladder and urethra. Risk factors include obesity, childbirth, chronic coughing, and constipation.(4)

About Duloxetine
Based on preclinical studies, duloxetine for SUI is a dual reuptake inhibitor and is believed to affect SUI by blocking the reuptake of serotonin and norepinephrine in the spinal cord.(3) The increase in the neurotransmitters in turn stimulates increased activity of the pudendal nerve that controls the external urethral sphincter. This stimulation is believed to increase contraction of the external urethral sphincter, thereby helping prevent accidental urine leakage with physical activity.

Clinical studies of duloxetine for the treatment of SUI have shown the most commonly reported adverse events (incidence of greater than or equal to 5 percent and significantly more common than placebo) reported by patients receiving duloxetine have been nausea, dry mouth, fatigue, insomnia, constipation, headache, dizziness, somnolence (drowsiness) and diarrhea.(5)

For full prescribing information, visit www.Cymbalta.com.

Source: Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc.

REFERENCES
1. Diokno A, Burgio K, Fultz N, Kinchen K, Obenchain R, and Bump R. Medical and self-care practices reported by women with urinary incontinence. Am J Managed Care. 2004;10:69-78. The estimate of STRESS URINARY INCONTINENCE prevalence was derived from Diokno et al and based on STRESS URINARY INCONTINENCE prevalence as determined by Hampel et al and by Diokno et al.

2. US Census 2000 Briefs (Age & Gender), US Department of Commerce Web site.

3. Thor K, Katofiasc M. Effects of duloxetine, a combined serotonin and norepinephrine reuptake inhibitor, on central neural control of lower urinary tract function in the chloralose-anesthetized female cat. J Pharmacol Exp Ther. 1995; 274:1014-1024.

4. Fultz NH, Burgio, K, Diokno A, Kinchen K, Obenchain R, and BumpR. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol. 2003; 189: 1275-1282.

5. Hurley D, Turner C, Baygani S, Yalcin I, and Viktrup L. Duloxetine for stress urinary incontinence: A meta-analysis of safety. Poster presented at the International Federation of Gynaecology and Obstetrics (FIGO) World Congress, Santiago, Chile. 2-7 November 2003.

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