From the FDA Drug Label
GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. (1.1) overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). (1.2)
The indication for Gemtesa (vibegron) is for the treatment of overactive bladder (OAB) with symptoms of:
- Urge urinary incontinence
- Urgency
- Urinary frequency in adults, including those with benign prostatic hyperplasia (BPH) who are on pharmacological therapy 1.
From the Research
Indication for Gemtesa (Vibegron)
The indication for Gemtesa (vibegron) is for the treatment of overactive bladder (OAB) symptoms, including:
- Urinary frequency
- Urgency
- Urgency incontinence
Clinical Trials and Studies
Studies have shown that vibegron is effective in improving OAB symptoms, with significant improvements in:
- Mean number of micturitions per day 2, 3, 4, 5
- Mean number of urgency episodes per day 2, 3, 4, 5
- Mean number of urgency incontinence episodes per day 2, 3, 4, 5
- Quality of life (QoL) 4, 5
Safety and Tolerability
Vibegron has been shown to be well-tolerated, with a favorable safety profile, and a low incidence of adverse events, including:
Approval and Availability
Vibegron was approved by the US Food and Drug Administration (FDA) for the treatment of OAB symptoms 2, and has also been approved in Japan for the same indication 6.