Presentations at International Continence Society Highlight Onset of Action, Urodynamic Data with Trospium, under Development by Indevus for Overactive Bladder
Thursday October 9, 9:00 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 9, 2003--Researchers at the 33rd Annual Meeting of the International Continence Society (ICS) in Florence, Italy, presented data on trospium, under development by Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News) to treat overactive bladder (OAB), regarding its onset of action and the correlation of patient diary-based data with urodynamic measurements.
In a presentation entitled "Trospium Chloride Improves Symptoms of Overactive Bladder Within One Week" (ICS 2003, abstract number 370), researchers presented data with trospium from a 523-patient, randomized, double-blind, placebo-controlled clinical trial conducted by Indevus at 51 clinical sites in the U.S. One objective of the trial was to evaluate the onset of action of trospium in reducing the symptoms of OAB, including frequency of voids and urge incontinent episodes, within the first week of treatment during the 12-week trial. Patients were evaluated at 1, 4 and 12 weeks. A 7-day patient diary was also collected during the first week of drug treatment to allow for a daily assessment of onset of activity.
Treatment with trospium was found to significantly reduce the frequency of voids at 3 days (p=0.05) when compared to placebo. Statistical trends toward this outcome were observed at days 4, 5 and 6. From day 7 through the 12-week end of the trial, a statistically significant reduction in frequency of voids was seen (p is less than 0.0001 at week 12). In addition, trospium was shown to significantly reduce the episodes of urge incontinent episodes at 7 days after beginning treatment (p=0.05) and through the end of the trial (p=0.01). Of note, this trial is also believed to be the first in OAB to pre-specify and to achieve the dual, co-primary endpoints of frequency of urination and the number of urge urinary incontinence episodes per 24 hours.
"Drug therapy for OAB has been historically affected by a delay in patients' symptomatic response to active drug agents," said Peter Sand, M.D., professor of obstetrics and gynecology, director, division of urogynecology and director, Evanston Continence Center, Northwestern University, Feinberg School of Medicine. "These data help establish the rapid onset of action of trospium and provide the opportunity for physicians to evaluate the effectiveness of therapy on a timely basis following its initiation."
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.
Another presentation at the ICS meeting, entitled "Urodynamic Observations Correlate with Patient Bladder Diary Measures of 24-Hour Frequency and Urge Urinary Incontinence" (ICS 2003, abstract number 420), offered rarely presented evidence of an association between traditional urodynamic data and clinical symptoms of OAB, based on data from a 358-patient, randomized, double-blind, active-controlled European trial. Reductions in 24-hour frequency and urge urinary incontinence episodes among patients treated with trospium, as measured by patient diaries, were shown to correlate significantly with standard laboratory measurements of bladder capacity that can be considered indicators of whether a patient is likely to have more or less voids or incontinent episodes per day.
"Few clinical studies have offered data establishing an association between urodynamic measurements and symptoms of OAB," said Bobby W. Sandage, Jr., Ph.D., executive vice president of research and development at Indevus. "Findings from this trial define a correlation between reductions in urinary frequency and urge urinary incontinence, based on patient diary data, and increases in bladder capacity, based on accepted laboratory parameters."
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 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 |
