Results Expected to be Delivered by November 2007
BARCELONA, Spain, October 9 /PRNewswire/ -- This double-blind, placebo-controlled and multi-center Phase II trial includes 332 patients with Overactive Bladder (OAB) and has been conducted at 77 sites in 11 countries (US, Germany, Spain, The Netherlands, Czech Republic, Hungary, Poland, Russia, South Africa, New Zealand and Australia). The company expects to report the results of this trial during November.
The total study treatment duration after screening and baseline has been 4 weeks. Patients have been randomized into one of five treatment arms, which include one placebo, one active control (Tolterodine, 4 mg once daily) and three SVT-40776 groups (once daily administration). The primary endpoint of the trial is the mean change from baseline to last day of treatment in the number of micturitions per day. The trial will also generate tolerability data.
"The successful completion of patient enrollment in this clinical trial represents an important milestone in the development of SVT-40776" said Jordi Julve, CEO.
"We are very excited to look at the data regarding the efficacy and safety of SVT-40776 and to confirm the excellent profile suggested by our previous clinical data. We expect that SVT-40776 will improve the efficacy/tolerability ratio compared to the current available treatments, being the treatment of choice for patients with OAB" continued Mr. Julve.
SVT-40776 is a new potent and selective M3 muscarinic antagonist for the treatment of OAB with high bladder/salivary gland selectivity, long half life and low metabolic rate. Compared to oxybutynin, tolterodine, solifenacin and darifenacin, SVT-40776 is the most potent and selective M3 vs M2 yet developed. This profile is expected to give SVT-40776 an improved efficacy and tolerability, increasing the benefit/risk ratio.
SALVAT is an independent, privately owned, Spanish pharmaceutical group closely identified with technological innovation and strongly committed to R&D. In 2006 SALVAT's products were distributed in more than 30 countries all over the world in collaboration with well reputed pharmaceutical partners. SALVAT is working to strengthen its international presence by licensing its own developments, e.g. CETRAXAL eardrops (currently under US-FDA review) and by emphasizing collaborations regarding its pipeline products.
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