FDA OKs New Treatment for Patients With Overactive Bladder

Officials with the FDA have approved vibegron (Gemtesa; Sumitovant Biopharma) 75 mg tablets for the treatment of patients with an overactive bladder (OAB).

According to Sumitovant, vibegron is the first new oral branded OAB medication approved by the FDA since 2012. In OAB, the bladder muscle contracts involuntarily, resulting in symptoms such as urinary urgency, urgency incontinence, frequent urination, and nocturia.

Vibegron is a once-daily, oral beta-3 adrenergic receptor agonist designed to treat symptom such as urge urinary incontinence (UUI), urgency, and urinary frequency in adults.

The approval was based on data from a clinical trial program involving more than 4000 patients with OAB, including the 12-week, double-blind, placebo-controlled phase 3 EMPOWUR study with a dose of 75 mg and the double-blind EMPOWUR long-term extension study. The results showed that treatment with vibegron significantly reduced daily UUI, micturitions, and urgency episodes, as well as an increase in the volume voided when compared with placebo.

According to clinical trial investigators, the data showing a reduction in urgency episodes is unique among currently available OAB treatments.

“Gemtesa is the first beta-3 agonist available as a once-daily pill which does not require dose titration,” David Staskin, MD, clinical trial investigator and a leading urologist with St. Elizabeth’s Medical Center in Boston, Massachusetts, said in a statement. “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.”

The most common adverse events (AEs) associated with vibegron from the study were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Vibegron demonstrated the same rates for the AEs of hypertension and increased blood pressure as placebo.

The FDA granted the approval for vibegron to Urovant Sciences, a member of the Sumitovant family of companies. Urovant Sciences plans to launch vibegron in the US in late first quarter of 2021.

Reference:

1. Sumitovant Biopharma Announces Urovant Sciences Receives US FDA Approval of Gemtesa (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB). News release. Sumitovant Biopharma; December 23, 2020. Accessed January 4, 2020. https://www.sumitovant.com/sumitovant-biopharma-announces-urovant-sciences-receives-u-s-fda-approval-of-gemtesa-vibegron-75-mg-tablets-for-the-treatment-of-patients-with-overactive-bladder-oab/