The Food and Drug Administration has expanded the indication for mirabegron (Myrbetriq/Myrbetriq Granules) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurologic impairment, in children aged 3 years and older.
This comes 1 year after the FDA approved solifenacin succinate, the first treatment of NDO in pediatric patients aged 2 years and older.
The approval of the drug for these new indications is a “positive step” for the treatment of NDO in young patients, Christine P. Nguyen, MD, director of the FDA’s Division of Urology, Obstetrics, and Gynecology, said in an FDA statement.
“Mirabegron, the active ingredient in Myrbetriq and Myrbetriq Granules, works by a different mechanism of action from the currently approved treatments, providing a new treatment option for these young patients. We remain committed to facilitating the development and approval of safe and effective therapies for pediatric NDO patients,” Dr. Nguyen said.
NDO is a bladder dysfunction that frequently occurs in patients with congenital conditions, such as spina bifida. It also occurs in people who suffer from other diseases or injuries of the nervous system, such as multiple sclerosis and spinal cord injury. Symptoms of the condition include urinary frequency and incontinence.
The condition is characterized by the overactivity of the bladder wall muscle, which is normally relaxed to allow storage of urine. Irregular bladder muscle contraction increases storage pressure and decreases the amount of urine the bladder can hold. This can also put the upper urinary tract at risk for deterioration and cause permanent damage to the kidneys.
The effectiveness of Myrbetriq and Myrbetriq Granules for pediatric NDO was determined in a study of 86 children and adolescents aged 3-17 years. The researchers found that after 24 weeks of treatment, the drug improved the patients’ bladder capacity, reduced the number of bladder wall muscle contractions, and improved the volume of urine that could be held. It also reduced the daily number of episodes of leakage.
Side effects of Myrbetriq and Myrbetriq Granules include urinary tract infection, cold symptoms, angioedema, constipation, and headache. The FDA said the drug may also increase blood pressure and may worsen blood pressure in patients who have a history of hypertension.
The FDA approved mirabegron in 2012 to treat overactive bladder in adults.
A version of this article first appeared on Medscape.com.