FDA Approves Oral Therapy for Pediatric Patients With Neurogenic Detrusor Overactivity

The FDA approval of solifenacin succinate marks the first for the treatment of young pediatric patients with NDO.

Officials with the FDA has approved solifenacin succinate (VESIcare LS, Astellas Pharma US) oral suspension for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children aged 2 years and older.1,2

Solifenacin succinate tablets were initially approved in 2004 for the treatment of overactive bladder in adults aged 18 years and older. The new approval is for solifenacin succinate in the form of a liquid, taken orally.1,2

Solifenacin succinate 5 mg/5 mL (1 mg/mL) oral suspension will be available by prescription in the United States in late 2020 and is also available in Europe.1

The FDA approval of solifenacin succinate marks the first for the treatment of young pediatric patients with NDO, according to Christine P. Nguyen, MD, acting director, FDA Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research.2

“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,” Nguyen said in a prepared statement.2

NDO results from disease or injury in the nervous system and may be related to congenital conditions, such as spina bifida or spinal cord injury. With NDO, there is overactivity of the bladder wall muscle, which normally relaxes to allow storage of urine. Bladder wall muscle overactivity results in sporadic bladder muscle contraction that increases pressure in the bladder and decreases the volume of urine it can hold.1,2

Solifenacin succinate is used to increase the amount of urine the bladder can hold and reduce urine leakage.1

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, frequency, and incontinence.2

The efficacy of solifenacin succinate oral suspension for this use was established in 2 clinical trials with 95 pediatric patients with NDO, aged 2 to 17 years. 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 aged 2 years to less than 5 years were able to hold an average of 39 mL more urine than when the study began. In the second study, 49 patients aged 5 years to 17 years were able to hold an average of 57 mL more urine than when the study began. Reductions in spontaneous bladder contractions, bladder pressure, and number of incontinence episodes were also observed in both studies.2

The most common adverse effects of solifenacin succinate oral suspension are constipation, dry mouth, and urinary tract infection. Sleepiness or drowsiness has been reported with use of solifenacin succinate. Patients of age who are able to drive or operate heavy machinery should not do so until they know how this drug affects them. Health care professionals are advised not to exceed the recommended starting dose of the medication in patients also taking strong CYP 3A4 inhibitors.2

Severe allergic reactions, such as angioedema 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.1,2

Solifenacin succinate oral suspension should not be used in patients with gastric retention, uncontrolled narrow angle glaucoma, or hypersensitivity to the drug or any of its components.1,2

Solifenacin succinate oral suspension 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, or at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval.1,2

REFERENCES

  • FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients [news release]. Northbrook, IL; May 27, 2020: Astellas website. https://newsroom.astellas.us/2020-05-27-FDA-Approves-VESIcare-LS-TM-solifenacin-succinate-Oral-Suspension-for-Pediatric-Patients Accessed May 27, 2020.
  • FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age [news release]. Silver Spring, MD; May 26, 2020: FDA website. Accessed May 27, 2020.