Overactive Bladder Treatment, Trospium Chloride, Does Not Affect Sleep Patterns in Older Adults

Main Category: Urology / Nephrology
Article Date: 08 Mar 2005 - 9:00 PDT

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Indevus Pharmaceuticals, Inc (NASDAQ: IDEV) today announced that a new study published in the January edition of British Journal of Urology demonstrates that trospium chloride, the active ingredient in SANCTURA(TM), marketed in the U.S. as a first-line therapy for overactive bladder (OAB), had no effect on the sleep patterns of older subjects (aged 51 to 65 years). Other currently marketed anticholinergic OAB treatments tested in this study were oxybutynin and tolterodine. Although OAB can occur in people of all ages, the incidence in older adults is higher.

"Patients with OAB tend to be elderly, and sleep disturbances in this patient population are problematic," said Dr. David Staskin, MD, associate professor of urology and obstetrics and gynecology at Weill-Cornell Medical College. "Anticholinergic drugs are the pharmacological treatment of choice for OAB. However, it is well recognized that side effects of this class of drugs can include undesirable central nervous system (CNS) effects such as impaired concentration, confusion, drowsiness and sleep disturbances. CNS side effects have rarely been reported with trospium chloride. Data indicating that trospium chloride is comparable to placebo in effects on REM sleep is important new information for the clinician."

The data in this study (Effects on sleep of anticholinergics used for overactive bladder treatment in healthy volunteers aged greater than or equal to 50 years, Diefenbach et al, British Journal of Urology 95, 346-349) were gathered from 24 healthy volunteers. The participants underwent four two-night periods of study in a sleep laboratory, with the study periods separated by a 12-day "washout" period. They were randomly assigned to receive one of the three medications or placebo. The duration of rapid-eye movement (REM) sleep, as a percentage of total sleep time, was selected as the primary outcome measure of the study.

Results showed that the proportion of the night spent in REM sleep after treatment with trospium chloride was not significantly different from placebo. In contrast, REM sleep was decreased by 14 percent after treatment with oxybutynin, compared with placebo (P=0.002), and by 15 percent after treatment with tolterodine compared with placebo (P=0.012).

REM sleep is an important component of normal sleep architecture. Disruptions in REM sleep can be caused by medications, psychiatric or medical illnesses, and sleep disorders. The elderly are generally more susceptible to these disruptions.

OAB is an often-embarrassing condition that also has social and psychological implications and affects an estimated 33 million Americans. Primary symptoms of OAB include: urgency (a sudden, intense desire to urinate); frequency (the need to urinate more than eight times a day); and urge urinary incontinence (the accidental loss of urine shortly after urgency).

Trospium chloride, the active ingredient in SANCTURA, possesses a unique quaternary amine structure and belongs to class of anticholineric compounds known as muscarinic receptor antagonists. These compounds work by relaxing the smooth muscle tissue found in the bladder, thus decreasing bladder contractions.

In clinical studies of SANCTURA for OAB, the most common adverse event versus placebo was dry mouth (20 percent versus 6 percent). Other commonly reported adverse events included constipation and headache. SANCTURA is contraindicated in patients who have, or who are at risk of, urinary retention, gastric retention, and uncontrolled narrow-angle glaucoma or who have demonstrated hypersensitivity to the drug or its ingredients.

About Indevus

Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology and infectious diseases. The Company currently markets SANCTURA for overactive bladder and has multiple compounds in clinical development, including pagoclone for stuttering, aminocandin for systemic fungal infections, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, and IP 751 for pain and inflammatory disorders such as interstitial cystitis.

Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA(TM) and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA and SANCTURA XR; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.

Katie Silverwood
Account Executive/Cohn & Wolfe Healthcare
292 Madison Ave/New York/NY/10017
t. 212.798.9844 f. 212.329.9900