Healthcare Industry News: pagoclone
News Release - March 6, 2006
Indevus Provides Update on Two Clinical ProgramsCompany Completes Enrollment in Phase II Trial for pagoclone and First Phase III Trial for SANCTURA XR(TM)
LEXINGTON, Mass.--(HSMN NewsFeed)--March 6, 2006--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV ) today reported that enrollment has been completed in the Company's Phase II trial for pagoclone, in development for stuttering, and the first of its two ongoing Phase III trials for SANCTURA XR. SANCTURA XR is the once daily formulation of SANCTURA®, which is currently marketed for overactive bladder.
"I am very pleased to report the completion of enrollment in both of these trials," said Glenn L. Cooper, M.D., chairman, president, and chief executive officer of Indevus. "Completing enrollment puts us on track to report data on the pagoclone trial by the middle of June of this year and report data on the first SANCTURA XR trial by the end of June."
"It is important that we recognize the large number of people who worked diligently on enrolling patients in these two trials," Dr. Cooper continued. "I would like to thank not only the Indevus regulatory, development and clinical staff for their dedication and focus but also the investigators working on both programs for their effort and support."
The Phase II trial enrolled approximately 130 patients in the largest controlled pharmaceutical trial ever conducted in stuttering. The trial is an 8-week, double-blind, placebo-controlled study evaluating the improvement in stuttering in adults receiving pagoclone versus placebo. Data is expected to be reported by the middle of June.
The first of two Phase III trials is fully enrolled with approximately 600 patients. Enrollment of the second trial is expected to be completed within the next 60 days. Both Phase III trials are 12-week, double-blind, placebo-controlled studies, evaluating the effect of SANCTURA XR in reducing frequency, urgency, and incontinence episodes in patients with overactive bladder. Consistent with previous guidance, the Company expects to file a New Drug Application with the U.S. Food and Drug Administration by the end of the calendar year.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology, gynecology and men's health. The Company currently markets SANCTURA® for overactive bladder and DELATESTRYL® for the treatment of male hypogonadism. The Company has multiple compounds in clinical development, including SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO® for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.
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 urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to SANCTURA should not use SANCTURA.
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® 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, SANCTURA XR and NEBIDO®; 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.
Source: Indevus Pharmaceuticals
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