Indevus Announces Positive Phase II Results for Sanctura XR; Trial Supports Phase III Initiation in Overactive Bladder.
The current trial was a two-week multi-center, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of SANCTURA XR in 148 patients with overactive bladder. The common symptoms of overactive bladder, such as urgency, frequency and incontinence episodes were measured daily. Volume voided was collected at the last two days of each week. In addition, several Quality of Life assessments were collected.
"Given the rapid onset of action of SANCTURA with efficacy seen within one week of therapy initiation, we had a unique opportunity to design an efficient pilot study of SANCTURA XR of only two weeks duration," said Bobby W. Sandage, Jr., Ph.D., executive vice president, research and development. "Previously in our 12 week Phase III trials of SANCTURA, we had observed rapid improvements in urgency, frequency, incontinence and volume voided and we were looking for similar findings with SANCTURA XR."
SANCTURA XR, administered as a single daily dose was found to improve all of the symptoms and signs of overactive bladder. The magnitude of improvement compared to placebo were very similar to those observed with SANCTURA in earlier studies. In addition, patients treated with SANCTURA XR indicated they had an improved quality of life compared to the placebo treated patients.
The most common anticholinergic side effects were dry mouth (8% of the placebo treated patients compared to 12% of the SANCTURA XR treated patients) and constipation (none reported in the placebo treated patients vs. 2% of the SANCTURA XR treated patients).
"We are pleased that this pilot study demonstrated that SANCTURA XR had an excellent efficacy and safety profile," said Glenn L. Cooper, M.D., president and CEO of Indevus. "We remain on schedule to initiate our Phase III program this summer with a goal of submitting an NDA in the second half of next year."
Trospium chloride 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.
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.
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 PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, pagoclone for stuttering, aminocandin for systemic fungal infections, and IP 751 for 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 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(R) 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 our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
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|Date:||Jun 15, 2005|
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