UK MHRA Approves Vibegron for Overactive Bladder Treatment in Adults

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light for the medication vibegron (Obgemsa) to address symptoms of overactive bladder (OAB) syndrome in adult patients. Indications might consist of a sudden urge to urinate (urgency), increased frequency of urination (urinary frequency), and loss of bladder control (urinary incontinence).

Pierre Fabre Limited was granted a new marketing authorization for vibegron (Obgemsa) on 17th July, 2024.

Vibegron, the active component in the medication, acts as a bladder muscle relaxant (a beta-3 adrenergic receptor agonist) that decreases the activity of an overactive bladder and addresses the associated symptoms. The suggested amount to take daily is one tablet. This medication is recommended in the form of a 75 mg tablet with a film coating.

This endorsement is backed by data from a phase 3 clinical study. The EMPOWUR trial assessed vibegron in 1,515 OAB patients over 12 weeks, displaying urgency and urinary frequency symptoms, with or without urge urinary incontinence. Patients were given one daily dose of either placebo (n=540), vibegron 75 mg (n=545), or active control (n=430).

The findings indicated that vibegron was successful in relieving OAB syndrome symptoms when compared to the placebo. Patients with overactive bladder syndrome experienced decreased daily urination and instances of incontinence. This was noticed after two weeks of the experiment and remained consistent for the entire 12-week duration of the therapy. The study results indicated that the benefits of the medication continue even after 52 weeks of therapy.