FDA approves treatment for form of bladder dysfunction in children
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The FDA announced that it has approved Astellas Pharma’s VESIcare LS oral suspension for the treatment of neurogenic detrusor overactivity, or NDO, in children aged 2 years and older.
Initially approved in 2004, VESIcare (solifenacin succinate) tablets have been used to treat overactive bladders in adults aged 18 years and older, according to the FDA.
NDO is a form of bladder dysfunction resulting from a disease or injury in the nervous system, the agency noted. It causes overactivity of the bladder wall muscle, which normally relaxes to allow storage of urine. The overactivity results in sporadic bladder muscle contraction, which then increases pressure in the bladder and decreases the volume of urine the bladder can hold.
“This is the first FDA-approved treatment for NDO patients as young as 2 years of age,” Christine P. Nguyen, MD, acting director of FDA’s Division of Urology, Obstetrics and Gynecology, said in a statement. “In addition, prior to [the] 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.”
If NDO is not treated, increased pressure in the bladder can put the upper urinary tract at risk and can cause permanent damage to the kidneys, according to the FDA. NDO also can lead to frequent and unexpected leakage of urine with symptoms of urinary urgency, frequency and incontinence.
The dysfunction could be related to congenital conditions that occur before or at birth, such as spina bifida, or other conditions related to injuries to the spinal cord, the FDA noted.
Two clinical trials tested the efficacy of solifenacin succinate among a total of 95 pediatric NDO patients aged between 2 and 17 years. The studies were designed to measure the maximum amount of urine the bladder could hold after 24 weeks of treatment.
In the first study, 17 patients aged between 2 and 4 years were able to hold an average of 39 mL more urine than at the beginning of the study, according to the FDA release. In the second study, 49 patients aged between 5 and 17 years were able to hold an average of 57 mL more urine than at the beginning of the study.
“Reductions in spontaneous bladder contractions, bladder pressure and number of incontinence episodes were also observed in both studies,” the release stated.
Common side effects of solifenacin succinate are constipation, dry mouth and UTIs. Drowsiness also has been reported.
Health care professionals are advised not to exceed the recommended starting dose for patients also taking strong CYP3A4 inhibitors.
Perspective
Back to TopGerald B. Whitman, MD
VESIcare tablets have been approved for adults with overactive bladders since 2004. The difference in the newly approved medication compared with the previously approved medication is the form of the medication.
The advantage for the pediatric patient of this new approval is that VESIcare is both a liquid and it is given only once daily. These changes will likely lead to better compliance by the patient because of the form of the medication, which is a long-acting liquid.
For a pediatrician with a typical patient mix, there would be relatively few patients who would benefit from this newly approved medication. Underlying neurologic issues causing this condition could include spinal trauma, tumors and spina bifida.
The studies done with VESIcare document a relaxation of the bladder muscles, leading to an increase in bladder capacity, which, in turn. will lead to less urinary urgency and frequency and, for older children the possibility of a decrease in urinary incontinence. This last advantage might be harder to evaluate in the younger ages because the child may not yet be toilet trained.
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