Background: Overactive bladder syndrome is a broadly occurring urological disorder with a distressing
impact on the quality of life. The commonly used antimuscarinic drugs show poor patient compliance because of
unsatisfactory potency, tolerability and high occurrence of adverse effects such as dry mouth, blurred vision, constipation,
dizziness etc. Mirabegron is the first approved β3-adrenoreceptor agonist, used as mono or in combination
therapies for overactive bladder syndrome.
Objective: The present review provides an insight into the mechanism, pharmacokinetics, toxicokinetics, clinical
trials and the development of various conventional and modified-release dosage forms of mirabegron for the treatment
of overactive bladder syndrome.
Results: The clinical trials of phase II and phase III of mirabegron demonstrated symptomatic relief from the overactive
bladder without disturbing the micturition cycle. To date, mirabegron showed promising results for safety, tolerability
and efficacy in patients with overactive bladder syndrome. The modified-release tablet dosage form of mirabegron
appear to be a proficient and suitable replacement for antimuscarinics and revealed the tremendous potential
to overcome the adverse effects of conventional antimuscarinic drugs like Oxybutyline chloride ER, Detrol LA,
Conclusion: Mirabegron shows a distinct mode of action, i.e., targeting β3-adrenoreceptors and improving bladder
storage without altering void contractions. The limited side effects, high safety, efficacy and tolerability of mirabegron
present an adequate substitute to antimuscarinics. However, long-term analysis and clinical studies are prerequisites
for assessing the safety, tolerability and efficacy profile of mirabegron.