Gemtesa® (vibegron; Urovant Sciences) is now available for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Gemtesa is an oral, once-daily, small molecule beta-3 adrenergic agonist. The approval was based on data from the pivotal phase 3 EMPOWUR study (ClinicalTrials.gov: NCT03492281), which included 1515 adults with OAB. Findings from the study showed that treatment with Gemtesa was associated with significant reductions in daily urge urinary incontinence (P <.001), micturitions (P <.001), urgency episodes (P =.002), and an increase in the volume voided (P <.001), when compared with placebo.
The most common adverse reactions reported with Gemtesa (incidence of greater than or equal to 2%) included headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Treatment with Gemtesa has been associated with urinary retention; the risk may be increased in patients with bladder outlet obstruction and in those taking muscarinic antagonist medications for OAB.
Gemtesa is supplied as 75mg tablets in 30- and 90-count bottles. The tablets can be swallowed whole or crushed and mixed with a tablespoon of applesauce for immediate administration with a glass of water.
1. Urovant Sciences announces U.S. commercial launch of Gemtesa® (vibegron) 75 mg tablets for patients with overactive bladder. [press release]. Irvine, CA & Basel, Switzerland: Urovant Sciences; April 12, 2021.
2. Gemtesa [package insert]. Irvine, CA: Urovant Sciences, Inc.; 2020.