New studies support the benefits of Betmiga/Myrbetriq (Astellas) for treating Overactive Bladder
New results from clinical trials of Betmiga (mirabegron), from Astellas, support the drug's good safety and tolerability profile in treating patients with Overactive Bladder. The first of the analyses � pooled from three randomised, placebo-controlled, double-blind, 12 week trials involving a total of 4,611 patients � shows there was a four-times lower incidence of dry mouth and pruritus in patients treated with mirabegron (1.7% and 0.2% respectively) vs the active-control tolterodine ER 4mg (10.1% and 1.4%), and comparable with placebo (2.1% and 0.4%).
The second study � three randomised, placebo-controlled, double-blind, 12-week trials and one 12 month study involving a total of 4,621 patients - shows treatment with mirabegron 50mg did not result in more cardiovascular AEs than treatment with the active-control tolterodine ER 4mg or in the placebo group. Betmiga received EU marketing approval in January 2013 and Myrbetriq received FDA approval in June 2012.