FDA 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.
The approval of VESIcare LS was granted to Astellas Pharma US, Inc.
Christine P. Nguyen, M.D., acting director, FDA’s Division of Urology
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.
NDO is a dysfunction of the bladder that results from disease or injury in the nervous system. NDO may be related to congenital conditions (often-inherited conditions beginning at or before birth), such as spina bifida (myelomeningocele), or other conditions such as spinal cord injury. With NDO, there is overactivity of the bladder wall muscle, which normally relaxes to allow storage of urine. The bladder wall muscle overactivity results in sporadic bladder muscle contraction, which increases pressure in the bladder and decreases the volume of urine the bladder can hold.
If NDO is not treated, increased pressure in the bladder can put the upper urinary tract at risk of harm, including possible permanent damage to the kidneys. In addition, spontaneous bladder muscle contractions can lead to unexpected and frequent leakage of urine with symptoms of urinary urgency (immediate urge to urinate), frequency (urinating more often than normal) and incontinence (loss of bladder control).