Indevus Announces Positive Phase II Results for Sanctura XR; Trial Supports Phase III Initiation in Overactive Bladder
15 June 2005, 08:45am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--June 15, 2005--Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV) today announced results from a pilot Phase II study of SANCTURA XR(TM), the new once daily formulation of SANCTURA(R). SANCTURA XR exhibited similar efficacy to previous results of the currently marketed SANCTURA which is given twice a day. In addition, SANCTURA XR was very well tolerated.
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.
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SOURCE: Indevus Pharmaceuticals, Inc. |
