FDA approves VESIcare for pediatric use

The US Food and Drug Administration has approved Astellas Pharma US Inc.’s VESIcare LS (solifenacin succinate) oral suspension for use in treating neurogenic detrusor overactivity (NDO) in children aged 2 years and older.¹ A tablet version of the drug was approved for treating overactive bladder in adults aged 18 years and older in 2004. The new treatment requires only once-a-day dosing.

Two clinical trials were used to establish the efficacy of VESIcare LS and included 95 pediatric patients with NDO aged 2 to 17 years. The studies were designed to measure the maximum amount of urine that the bladder could hold following 24 weeks of treatment. In study one, 17 pages aged 2 years to younger than 5 years were able to hold an average of 39 mL more urine following treatment. The second study included 49 patients aged 5 to 17 years who were able to hold an average of 57 mL more urine after treatment. Additionally, the researchers observed reductions in bladder pressure, number of incontinence episodes, and spontaneous bladder contractions in both studies.

The most common adverse effects were constipation, dry mouth, and urinary tract infection. Sleepiness or drowsiness has been reported with solifenacin succinate and patients of age who can drive should be advised to refrain from doing so until they know how VESIcare LS affects them. The recommended starting dose should not be exceeded in patients who also are taking strong CYP3A4 inhibitors. Anaphylaxis and angioedema have been reported. The drug should not be used in patients with gastric retention, uncontrolled narrow angle glaucoma, or hypersensitivity to VESIcare LS.

References:

1. US Food and Drug Administration. FDA approves first treatment for a form of bladder dysfunction in pediatric patients as young as 2 years of age. US Food and Drug Administration. Published May 26, 2020. Accessed May 27, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-form-bladder-dysfunction-pediatric-patients-young-2-years-age?utm_campaign=052620_PR_FDA%20Approves%20Treatment%20for%20a%20Form%20of%20Bladder%20Dysfunction&utm_medium=email&utm_source=Eloqua