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

Food and Drug Administration (FDA)

WASHINGTON, D.C. — The U.S. Food and Drug Administration 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 [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.

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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).

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.

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Reductions in spontaneous bladder contractions, bladder pressure and number of incontinence episodes were also observed in both studies.

The most common side effects of VESIcare LS are constipation, dry mouth and urinary tract infection. Somnolence (sleepiness or drowsiness) has been reported with solifenacin succinate, the active ingredient in VESIcare LS.

Patients of age who are able to drive or operate heavy machinery should not do so until they know how VESIcare LS affects them. Health care professionals are advised not to exceed the recommended starting dose of VESIcare LS in patients also taking strong CYP3A4 inhibitors.

Severe allergic reactions, such as angioedema (swelling beneath the skin) and anaphylaxis, have been reported in patients treated with solifenacin succinate and may be life threatening. Patients should seek immediate attention if they experience swelling of the tongue or throat or difficulty breathing.

VESIcare LS is not to be used in patients with gastric retention (reduced emptying of the stomach), uncontrolled narrow angle glaucoma (fluid buildup in the eye which raises eye pressure) or hypersensitivity (allergic reaction) to VESIcare LS or any of its components.

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VESIcare LS is also not recommended for use in patients with severe liver failure, clinically significant bladder outlet obstruction in the absence of clean intermittent catheterization, decreased gastrointestinal motility (slowed intestinal contractions), or at high risk of QT prolongation (an electrical disturbance where the heart muscle takes longer than normal to recharge between beats), including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval.

The approval of VESIcare LS was granted to Astellas Pharma US, Inc.

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