Open label long term study:
LEXINGTON, Mass., Jul 29, 2004 (BUSINESS WIRE) -- Indevus Pharmaceuticals, Inc. (IDEV) today announced that data presented today at the annual meeting of the American Urogynecological Society showed that long-term treatment with SANCTURA(TM) (trospium chloride tablets) extended relief from the symptoms of overactive bladder and was well tolerated. SANCTURA was recently approved by the U.S. Food and Drug Administration (FDA) and is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
The data were gathered from a 12-month study that included a three-month, randomized, double-blind, placebo-controlled Phase III clinical trial, followed by a nine-month open-label period. During the initial 12-week period, patients were treated with either SANCTURA or placebo. Patients on SANCTURA had a statistically significant reduction in frequency of urination and urge incontinence episodes, as well as an increase in volume voided, compared to placebo-treated patients. At the end of the 12-week period, SANCTURA patients continued their treatment for an additional nine months, while placebo patients were switched to SANCTURA. Following treatment for up to one year, patients continuing on SANCTURA treatment maintained comparable and sustained efficacy for the entire treatment period. Patients who crossed over from placebo to SANCTURA rapidly experienced a similar degree of efficacy which was also sustained for the entire nine-month period.
Regardless of initial treatment, at 12 months the mean reduction in frequency of urination for all patients ranged from 18 to 21 voids per week, and the mean reduction in urge incontinence episodes ranged from 64 percent to 72 percent per day, compared to baseline. All patients experienced an increase of 27 to 28 milliliters in volume voided at the end of the study. Treatment with SANCTURA was also well tolerated, and the most frequently reported adverse events were dry mouth at 11.3 percent and constipation at 8.8 percent.
"Long-term efficacy with SANCTURA therapy was demonstrated in this open-label study, as was improved tolerability to the drug," said Norman Zinner, M.D., associate professor of urology at the University of California, Los Angeles (UCLA) and lead investigator on this trial. "In fact, the long-term use of antimuscarinic agents has been characterized to a significant degree by lack of tolerability, and it is noteworthy that long-term use of SANCTURA has led to improved tolerability which we believe will help maintain a higher level of compliance."
A total of 523 patients were studied in the original 12-week trial, which was included in the New Drug Application (NDA) for SANCTURA approved by the U.S. Food and Drug Administration (FDA) on May 28, 2004. A total of 407 of these patients opted to continue treatment into the open-label phase of this trial. Two hundred and four patients originally randomized to placebo in the double-blind phase were switched to SANCTURA, while 203 patients continued with SANCTURA treatment. |
