Indevus' Trospium Shown to Reduce Urgency Severity Among
Patients with Overactive Bladder
Tuesday October 7, 9:04 am ET
Presentations at International Continence Society Highlight Capabilities of Trospium
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 7, 2003-- Presentations of clinical data at the 33rd Annual Meeting of the International Continence Society (ICS) in Florence, Italy highlighted the effect of trospium, under development by Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News), on urgency severity, a hallmark symptom among patients with overactive bladder (OAB). Trospium is an anticholinergic compound currently under regulatory review in the U.S. to treat OAB.
In a presentation entitled "The Effect of Anticholinergic Therapy on Urgency Severity in Patients with Overactive Bladder: Clinical Assessment of a Newly Validated Tool" (ICS 2003, abstract number 33), a team of researchers led by Roger Dmochowski, M.D., Medical Director, Vanderbilt University, Department of Urologic Surgery, examined data from a 523-patient, randomized, double-blind, placebo-controlled clinical trial with trospium conducted by Indevus at 51 clinical sites in the U.S.
Data analysis from this trial showed that treatment with trospium significantly reduced urgency severity. Trospium-treated patients progressed from experiencing, on average, a "moderate" degree of urgency with each toilet void to experiencing a "mild" degree of urgency with each void (p(Less than or equal to)0.0001). Placebo patients had no notable change in the severity of their urgency. In addition, treatment with trospium achieved the co-primary endpoints in this trial by reducing both the frequency of urination (p(Less than)0.0001) and the number of urge urinary incontinence episodes (p(Less than)0.0001) per 24 hours, compared to treatment with placebo. This trial is believed to be the first in OAB to pre-specify and to achieve these dual endpoints.
"In daily practice, urgency is the predominant symptom among patients with overactive bladder," said Dr. Dmochowski. "Consequently, the treatment of urgency severity has emerged as an important objective for physicians managing these patients. Traditionally, clinical studies with anticholinergic agents designed to treat OAB have focused on urge frequency and urge incontinence rather than severity. This trial with trospium was designed to examine the impact of such an agent on severity, and the data demonstrate a clear benefit to patients for whom urgency represents a common and life-altering condition."
Clinical trials of OAB have traditionally focused on urge urinary incontinence and its prevalence, often overlooking 24-hour frequency and urgency, the more common symptoms of this disorder, largely due to the lack of a validated measurement scale for quantifying urgency severity.
In measuring urgency severity, researchers in this trial used for the first time the Indevus Urgency Severity Scale (IUSS©), a new patient-reported outcome assessment instrument that asks patients to rate their urgency severity prior to voiding. A separate presentation delivered at ICS, entitled "Feasibility of Retrospective Psychometric Validation: Example of the Indevus Urgency Severity Scale (IUSS) for Patients with Overactive Bladder" (ICS 2003, abstract number 119), demonstrated that this scale was a valid measure for assessing urgency.
Trospium was well tolerated in this trial as evidenced by its adverse event profile that included the most common adverse events associated with the antimuscarinic class of drugs, dry mouth and constipation. The incidence of dry mouth observed in trospium patients was 21.8 percent, while constipation was observed in 9.5 percent of these patients.
Background
Trospium belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.
Trospium possesses a quarternary ammonium structure. In animal studies, the compound does not appear to cross the blood-brain barrier. At therapeutic concentrations in vitro, trospium does not interact with drugs metabolized by the Cytochrome P-450 system, a metabolic pathway commonly associated with drug-drug interactions, and it is excreted largely unchanged in the urine.
Trospium has been extensively studied and is currently marketed as a prescription drug product in Europe, where it is one of the leading products for overactive bladder and urinary incontinence. Indevus licensed exclusive U.S. rights to trospium from Madaus AG, a German pharmaceutical company, in late 1999. The Company submitted the New Drug Application (NDA) for trospium on April 28, 2003, and on June 27, 2003, the U.S. Food and Drug Administration (FDA) accepted the NDA for review.
The American Foundation of Urologic Disorders estimates that more than 17 million Americans, 85 percent of whom are women, suffer from OAB in the U.S. OAB is defined as urge incontinence, urgency and frequency of urination and is the leading cause of nursing home admissions, with an estimated 50 percent of nursing home residents suffering from this condition.
In 2002, the market for drugs to treat OAB was approximately $1 billion and growing at over 30 percent annually, according to IMS data. Independent consultants Wood Mackenzie forecast sales of OAB medicines to grow at a compound annual rate of 22.5 percent this decade. The current OAB market is defined by patients who are highly dissatisfied, with over 70 percent of patients discontinuing therapy after six months, according to data from NDC Healthcare.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in late-stage clinical development. The Company currently has six compounds in development: trospium for overactive bladder, pagoclone for panic and generalized anxiety disorders, citicoline for ischemic stroke, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and aminocandin for systemic fungal infections.
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 trospium; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly trospium; risks associated with contractual agreements; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the commercialization of trospium and for the development of pagoclone and citicoline; 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.
Contact:
Indevus Pharmaceuticals, Inc.
Michael W. Rogers, 781-861-8444
William B. Boni, 781-402-3410
Source: Indevus Pharmaceuticals, Inc. |
