USFDA clears solifenacin succinate for neurogenic detrusor overactivity in children

May 27, 2020 0 By FM

An oral suspension of solifenacin succinate (VESIcare LS), indicated for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction due to neurological impairment was cleared by the US FDA for use in children of two years and older.

NDO is a dysfunction of the bladder that results from disease or injury to the nervous system. Congenital conditions like spina bifida (myelomeningocele), or spinal cord injury may also be responsible for the disorder.

NDO causes overactivity of the bladder wall muscle causing sporadic bladder muscle contraction which in turn decreases the normal capacity of the bladder to hold urine. Under untreated conditions, the increased pressure in the bladder can put the upper urinary tract at risk of harm, including possible permanent damage to the kidneys and incontinence. 
The most common side effects of solifenacin succinate found during the study were drowsiness, constipation, dry mouth and urinary tract infection.

The FDA directs health care professionals to not exceed the recommended starting dose of the drug in patients also taking strong CYP3A4 inhibitors. Severe allergic reactions, such as angioedema and anaphylaxis, have also been reported in patients treated with solifenacin succinate.

“..The current standard of care for many of these (NDO) patients required up to three times a day dosing, and this treatment requires only once a day dosing.” 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.

Astellas Pharma US, Inc. received the nod for the production of the drug.