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New overactive bladder treatment approved by FDA

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Myrbetriq (mirabegron) from Astellas is the first beta-3 adrenergic agonist accepted for OAB


 

The US Food and Drug Administration (FDA) has approved Myrbetriq™ (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

“Myrbetriq is the first oral OAB treatment with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago,” said Steven Ryder, MD, president of Astellas Pharma Global Development. “The approval of Myrbetriq represents an important milestone in OAB treatment and in our ongoing commitment to advancing urological health.” Astellas Pharma US, Inc., is a subsidiary of Tokyo-based Astellas Pharma Inc.

Myrbetriq, a once-daily oral beta-3 adrenergic agonist, offers a new treatment option for patients with OAB. Antimuscarinics, the current OAB treatment standard, work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Myrbetriq relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 adrenergic receptors, therefore increasing bladder capacity.

Myrbetriq has been studied in more than 10,000 individuals over 10 years. FDA approval was based on safety and efficacy data from three placebo-controlled Phase 3 studies in which treatment with Myrbetriq 25 mg and 50 mg resulted in statistically significantly improvement in efficacy parameters of incontinence episodes and number of urinations per 24 hours.

The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. The dose may be increased to 50 mg. Most commonly reported adverse reactions were hypertension, nasopharyngitis, urinary tract infection, and headache. Myrbetriq will be available in pharmacies in the fourth quarter of 2012.

For additional information, visit www.myrbetriq.com.

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