HealthDay News — The FDA has approved Myrbetriq (mirabegron, Astellas Pharma) to treat adults with overactive bladder, a condition affecting some 33 million Americans.
The drug is designed to relax the bladder muscle as the bladder fills, minimizing symptoms of needing to urinate too often, needing to urinate immediately or the involuntary leakage of urine, the agency said in a press release.
The approval came after results from three double-blind, placebo-controlled, multicenter clinical trials involving 4,116 people with overactive bladder showed the drug was safe and effective.
Patients were randomly assigned to Myrbetriq 25 mg, 50 mg, 100 mg or placebo once daily for 12 weeks. Those in the 25 mg and 50 mg groups had significantly fewer episodes of urination and wetting accidents in a 24-hour period than those assigned to placebo. Patients taking 50 mg doses also expelled a greater amount of urine, which demonstrates the drug’s effectiveness at improving bladder capacity.
The most common side effects were elevated BP, cold-like symptoms, urinary tract infection, constipation, fatigue, increased heart rate and abdominal pain.