FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

发布时间： 2020-05-29 阅读：676次

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May 26, 2020-- The U.S. Food and Drug Administration today granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older. VESIcare (solifenacin succinate) tablets were initially approved in 2004 for the treatment of overactive bladder in adults 18 years and older.

“This is the first FDA-approved treatment for NDO patients as young as two years of age,” said Christine P. Nguyen, M.D., acting director, FDA’s Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. “In addition, prior to today’s approval, the current standard of care for many of these patients required up to three times a day dosing, and this treatment requires only once a day dosing.”

The efficacy of VESIcare LS for this use was established in two clinical trials with a total of 95 pediatric NDO patients, ages two to 17 years old. The studies were designed to measure (as a primary efficacy endpoint) the maximum amount of urine the bladder could hold after 24 weeks of treatment. In the first study, 17 patients ages 2 to less than 5 years old were able to hold an average of 39 mL more urine than when the study began. In the second study, 49 patients ages five to 17 years were able to hold an average of 57 mL more urine than when the study began. Reductions in spontaneous bladder contractions, bladder pressure and number of incontinence episodes were also observed in both studies.