Early Patient Response Predicts Long-Term Success of Therapy With Indevus' Trospium for Overactive Bladder
Tuesday October 14, 9:05 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 14, 2003--Clinical data presented at the American Urology Association's New York Sectional Meeting (October 11-18, Athens, Greece) demonstrated that early patient response to treatment with trospium for overactive bladder (OAB) is an accurate predictor of long-term therapeutic success. Trospium is an anticholinergic compound under development by Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News).
In a presentation entitled "A Method of Predicting Which Overactive Bladder (OAB) Patients Will Respond to Medical Treatment," researchers led by David R. Staskin, M.D., director, section of voiding dysfunction, New York Presbyterian Hospital and associate professor of urology and obstetrics and gynecology at Weill-Cornell Medical College, analyzed data from a 523-patient, randomized, double-blind, placebo-controlled, 12-week clinical trial with trospium conducted by Indevus at 51 clinical sites in the U.S.
Data analysis focused on the identification of variable predictive factors that could be used to determine potential responders to treatment, who were defined as patients with at least a 50 percent reduction in urge incontinence (UI) episodes at week 12 of the trial. Variables subjected to analysis included treatment (i.e. trospium or placebo), gender, age and evidence of a single UI episode reduction in the first treatment week.
Researchers found that the reduction of a single UI episode from baseline to the end of week 1 was predictive of a 50 percent reduction in UI episodes at week 12. No other variable, except for treatment with trospium, predicted long-term success. Of the trospium-treated patients, 83 percent experienced UI episode reduction in the first treatment week, and 79 percent of these patients experienced 50 percent or greater reduction in UI episodes at week 12. Seventeen percent of trospium patients did not experience UI episode reduction in the first week of treatment, and 33 percent of those patients did not respond to treatment by week 12.
"Predicting the symptomatic response of overactive bladder patients to therapy has been a challenge, and physicians have sought early indicators of such a response to determine the benefits of continued, long-term treatment," said Dr. Staskin. "As previously shown, the rapid onset of action of trospium in reducing the frequency of voids and the episodes of urge incontinence within one week has provided the opportunity for physicians to evaluate therapeutic efficacy on a timely basis following initiation of therapy. Building upon this finding, additional data analysis from this trial demonstrates that patient response to trospium within one week is in fact a valid predictor of long-term therapeutic success and that lack of such a response is a predictor of those patients unlikely to achieve this success. These data provide physicians with a valuable analytical tool to monitor patient response, establish expectations of continued therapeutic efficacy, and help improve patient compliance."
Notably, treatment with trospium also 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, at the 12-week end of the trial. 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
Michael W. Rogers, 781-861-8444
or
William B. Boni, 781-402-3410
Source: Indevus Pharmaceuticals |
