The Food and Drug Administration (FDA) has approved Gemtesa® (vibegron; Urovant Sciences) 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 in which patients were randomized to receive vibegron 75mg (n=545) once daily, placebo (n=540), or tolterodine extended-release 4mg (n=430) once daily for 12 weeks.
The co-primary end points were change from baseline in average daily number of micturitions and average daily number of urge urinary incontinence (UUI) episodes at week 12; secondary end points included change from baseline in average daily number of urgency episodes and average volume voided per micturition. Findings showed that treatment with vibegron was associated with statistically significant reductions in daily UUI (P <.001), micturitions (P <.001), and urgency episodes (P =.002), and an increase in the volume voided (P <.001), when compared with placebo.
As for safety, the most common adverse reactions reported with Gemtesa included headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Additionally, urinary retention has been observed in Gemtesa-treated patients; the risk is increased in patients with bladder outlet obstruction and in those taking muscarinic antagonist medications for OAB.
“Gemtesa is the first beta 3-agonist available as a once-daily pill which does not require dose titration,” said David Staskin, MD, clinical trial investigator and a leading urologist with St. Elizabeth’s Medical Center in Boston. “Notably, Gemtesa did not have any increase in the adverse event of hypertension compared to placebo in the key EMPOWUR study and has no interactions with medications metabolized by CYP2D6, which is important since many common medications are metabolized by CYP2D6.”
Gemtesa is supplied as 75mg tablets and is expected to be available in the first quarter of 2021.
- Urovant Sciences announces US FDA approval of Gemtesa® (vibegron) 75 mg tablets for the treatment of patients with overactive bladder (OAB). [press release]. December 23, 2020.
- Gemtesa [prescribing information]. Irvine, CA: Urovant Sciences; 2020.