December 23, 2020 – The U.S. FDA has approved Gemtesa® (vibegron), manufactured by Urovant Sciences, to treat overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults.

OAB occurs when the bladder contracts involuntarily. This can cause an urgent need to urinate, unintentional urination immediately following an urgent need to urinate (also known as UUI), unusually frequent urination, and nocturia (the need to get up two or more times a night to urinate).

In a clinical study, Gemtesa delivered statistically significant reductions in daily UUI, urination, and urgency episodes compared to placebo. Gemtesa works by helping to relax the detrusor bladder muscle, which allows the bladder to hold more urine and leads to a reduction in the symptoms of OAB.

Recommended dosing is one 75mg tablet taken once a day. It can either be swallowed whole with water or crashed and mixed with applesauce.

Urovant plans to launch Gemtesa in the first quarter of 2021 at a wholesale acquisition cost (WAC) of $458.40 per 30 tablets.