FDA Approves New Indication for Drug to Treat Neurogenic Det
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The U.S. Food and Drug Administration approved a new indication for Myrbetriq and Myrbetriq Granules to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients.

NDO is a dysfunction of the bladder that results from congenital conditions such as spina bifida. With NDO, there is overactivity in the bladder wall muscle, which normally relaxes to allow storage of urine. If NDO is not treated, increased pressure 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.

The efficacy of Myrbetriq and Myrbetriq Granules for the pediatric NDO indication was established in a study of 86 patients ages 3 to 17 years old. Improvements occurred in patients’ maximum cystometric capacity, number of detrusor contractions, volume of urine held until first detrusor contraction and number of daily urine leakage episodes after 24 weeks of treatment.

The most common side effects with NDO were urinary tract infection, nasopharyngitis, constipation and headache. Myrbetriq and Myr Betriq Granules may cause angioedema, an allergic reaction with swelling of the lips, face, tongue or throat. They may also increase blood pressure and make blood pressure worse in patients with a history of high blood pressure.

Myrbetriq and Myrbetriq Granules are two different products and they are not substitutable on a milligram-per-milligram basis. A recommended dosage for Myrbetriq Granules for adults has not been determined. The FDA granted the approval of Myrbetriq and Myrbetriq Granules to Astellas Pharma US, Inc.