The Food and Drug Administration (FDA) has approved Myr Betriq® (mirabegron extended-release tablets) and Myr Betriq® granules (mirabegron for oral extended-release suspension) for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients. Both formulations are indicated for patients 3 years and older; However, the tablet formulation is specifically approved for patients weighing 35 kg or more.
NDO is a neurological bladder dysfunction that is commonly seen in children with spina bifida and causes symptoms of urination, frequency, and incontinence. The approval was based on data from an open phase 3 study (ClinicalTrials.gov: NCT02751931) in which 91 patients aged 3 to 17 years with NDO and clean intermittent catheterization enrolled.
The results showed that treatment with mirabegron resulted in an improvement in maximal cystometric capacity at week 24 (primary endpoint). Improvements were also seen in several secondary endpoints, including the number of overactive detrusor contractions, the volume of urine held until the first detrusor contraction, and the number of daily urine leakage episodes.
In terms of safety, UTI, nasopharyngitis, constipation, and headache were the most commonly reported adverse reactions with mirabegron in pediatric patients with NDO. Increases in blood pressure have also been associated with treatment with mirabegron and may be greater in children than in adolescents.
The prolonged-release tablet comes in strengths of 25 and 50 mg and is currently available. The Myr Betriq granules, which contain 8 mg / ml mirabegron after reconstitution, are expected to be available by the end of 2021.
1. The FDA approves a new indication for a drug to treat the overactivity of neurogenic detrusors in pediatric patients. [press release]. Silver Spring, MD: US Food and Drug Administration; March 25, 2021.
2. Myr Betriq® [package insert]. Northbrook, IL: Astellas Pharma; 2021.
This article originally appeared on MPR
Neuromuscular Disorders Pediatric Neurological Treatments