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Odyssey Pharmaceuticals and Indevus Pharmaceuticals Announce Odyssey's Plans to Initiate Phase IV Open Label Study of the Effectiveness and Safety of SANCTURA in Patients With Overactive Bladder Symptoms

Posted on: Tuesday, 15 March 2005, 09:00 CST

Odyssey Pharmaceuticals, Inc. and Indevus Pharmaceuticals, Inc., (NASDAQ: IDEV) today announced that Odyssey plans to initiate this month a Phase IV study of the effectiveness and safety of SANCTURA(TM) (trospium chloride) in patients with overactive bladder (OAB) symptoms. Following FDA approval of SANCTURA in May 2004 for the treatment of OAB, the product has been launched and is being well-received by urologists in the U.S.

Odyssey's SECURE (SANCTURA Study to Evaluate Control of Urinary Symptoms Resulting From Overactive Bladder) trial will be the largest OAB study ever conducted, enrolling about 4,000 patients. It will be a multi-center, prospective study conducted in the United States.

"Overactive bladder, with or without urge incontinence, affects one's quality of life, impacting physical, emotional and mental health," stated Eboo Versi, M.D., Ph.D., senior vice president of medical affairs of Odyssey. "Unlike many OAB studies in the past, which focused on tracking daily urinary activities, this study will be concerned primarily with what affects the lifestyle of a patient with OAB symptoms," added Dr. Versi.

According to Dr. Alan Garely, Chief, Urogynecology and Pelvic Reconstructive Surgery at Winthrop University Hospital in New York and co-principal investigator of SECURE, "the design and objectives of this study are unique and innovative. The study will broaden our understanding of OAB by answering for the first time questions that have not been asked of OAB patients before."

Dr. David Sussman, Chief of Urology, Kennedy Health System in New Jersey and co-principal investigator of SECURE, added, "This innovative study will provide important measurements to assess the effect that SANCTURA(TM) has on improving the daily lives of patients whose activities are often interrupted by or who are embarrassed by OAB symptoms."

Dr. Versi said, "I join Dr. Garely and Dr. Sussman in a shared excitement about leading this large-scale study, as it is designed to yield important ground-breaking scientific data to increase understanding of the impact of OAB on the lives of patients. We hope to expand the clinical literature about OAB and thereby help patients, their families and caregivers."

SANCTURA is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The most commonly reported side effects in Phase III U.S. clinical trials were dry mouth (20.1 percent for SANCTURA vs. 5.8 percent for placebo) and constipation (9.6 percent for SANCTURA vs. 4.6 percent for placebo). Patients who have or are at risk for urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to SANCTURA should not use SANCTURA.

SANCTURA is co-promoted by Odyssey Pharmaceuticals, Inc. and Indevus Pharmaceuticals, Inc. For more information about SANCTURA, including indications, contraindications and other safety information, please go to www.Sanctura.com or call 877-427-9068.

About Odyssey

Odyssey Pharmaceuticals, Inc., a subsidiary of PLIVA, d.d., is a specialty pharmaceutical company dedicated to the research, development and commercialization of innovative products to improve quality of life. Since 2000, Odyssey has concentrated on key therapeutic categories such as urology, respiratory and central nervous system. The company recently launched SANCTURA(TM), a prescription medicine that is indicated for the treatment of overactive bladder (OAB). An estimated 33 million Americans suffer from OAB, with symptoms of urge urinary incontinence, urgency and urinary frequency.

With more than 80 years of experience in the pharmaceuticals area, PLIVA d.d., headquartered in Zagreb, Croatia, is now a global generics and specialty company, with operations in more than 30 countries in the U.S., Central and Eastern Europe and Western Europe. Building upon a strong R&D history, the company specializes in the discovery, development, production and distribution of generic and branded pharmaceutical products. Since its listing on the London Stock Exchange in 1996, PLIVA has established a fully internationalized business, with the majority of its revenues now realized in Western markets.

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 Indevus Pharmaceuticals, Inc.'s (the " Company") 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 the Company's Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.

Source: Business Wire

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