The Food and Drug Administration (FDA) has approved Vesicare LS (solifenacin succinate; Astellas Pharma) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 2 years of age and older.

Solifenacin is a competitive muscarinic receptor antagonist that is also approved in tablet form for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The approval for NDO was based on data from 2 clinical trials that included 95 patients (aged 2-17 years). Patients were administered solifenacin oral suspension once a day. The primary end point of both studies was the change from baseline to Week 24 in maximum cystometric capacity, defined as the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.

Results of the first study showed that compared to baseline, patients aged 2 to <5 years (n=17) were able to hold on average 39mL more urine. In the second study, which included patients 5-17 years old (n=49), the mean change from baseline in maximum cystometric capacity was 57mL. In both studies, reductions in spontaneous bladder contractions, bladder pressure, and number of incontinence episodes (all secondary end points) were noted. With regard to safety, the most common adverse reactions reported included constipation, dry mouth and urinary tract infection. 

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“This is the first FDA-approved treatment for NDO patients as young as 2 years of age,” said Christine P. Nguyen, MD, 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 3 times a day dosing, and this treatment requires only once a day dosing.”

Vesicare LS is supplied as 1mg/mL oral suspension and is expected to be available in late 2020.

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