Astellas reported positive data from a pivotal Phase III trial evaluating its overactive bladder therapy candidate mirabegron. The data showed that 12 weeks of treatment with mirabegron once daily led to significant improvements in the number of incontinence episodes, the frequency of urination per 24 hours, and patient-reported outcomes including disease perception, symptom bother, and quality of life.
“These findings are very promising since mirabegron will represent the first oral overactive bladder treatment with a new, distinct mode of action in nearly 30 years,” commented principal trial investigator Victro Nitti, M.D., who is vice chair of urology and professor of urology at New York University’s Langone Medical Center. “Unlike other overactive bladder treatments, mirabegron works by improving the storage capacity of the bladder without affecting voiding contractions.”
Mirabegron is a selective beta-3 adrenoceptor antagonist designed to facilitate filling of the bladder and storage of urine. A marketing authorization application for the drug was submitted in Japan in June 2010. Astellas expects to make regulatory filings in the U.S. and Europe during the second half of 2011.
Astellas’ existing marketed overactive bladder treatment, Vesicare® (solifenacin succinate), is a muscarine receptor antagonist that acts by blocking the muscarinic receptors in bladder smooth muscle to improve symptoms such as urinary frequency, urgency, and urge incontinence. Launched in Europe in 2004, the drug is marketed in over 60 countries. Last month Astellas launched a new orally disintegrating tablet formulation of the drug, Vesicare®OD, in Japan.