NEW ORLEANS, LA – The U.S. Food and Drug Administration (FDA) has approved GEMTESA (vibegron) 75 mg, a once-daily oral beta-3 adrenergic receptor agonist developed by Urovant Sciences, for the treatment of adults with overactive bladder (OAB) symptoms including urge urinary incontinence (UUI), urgency, and urinary frequency.

Dr. Nathan Fischman, Principal Investigator at Touro Medical Center in New Orleans, contributed to the pivotal clinical trial through DelRicht Research. Dr. Fischman has led various clinical trials across multiple therapeutic areas since 2016, playing an important role in advancing treatment options for urologic and other chronic conditions.

GEMTESA: A Long-Awaited Advancement in OAB Care

GEMTESA is the first new branded oral OAB therapy approved since 2012 and the first FDA-approved product for Urovant Sciences. Unlike earlier treatments, GEMTESA offers once-daily dosing with no need for titration and does not increase the risk of hypertension compared to placebo. These features represent a meaningful improvement in tolerability and ease of use for the estimated 30 million Americans living with OAB.

“We are proud to have supported Dr. Fischman and the Touro Medical team in this groundbreaking study,” said Rachel Hastings, Managing Partner at DelRicht Research. “This approval is a win for patients seeking modern, better-tolerated options to manage the daily impact of OAB.”

“We are proud to have supported Dr. Fischman and the Touro Medical team in this groundbreaking study. This approval is a win for patients seeking modern, better-tolerated options to manage the daily impact of OAB.”

— Rachel Hastings, Managing Partner at DelRicht Research

Strong Clinical Efficacy with a Favorable Safety Profile

FDA approval was based on results from Urovant’s EMPOWUR Phase 3 program, which enrolled over 4,000 patients and showed that GEMTESA significantly reduced daily urgency episodes, UUI, and urination frequency compared to placebo. It also improved bladder capacity without raising blood pressure or interacting with commonly prescribed medications.

The most common side effects included headache, nasopharyngitis, and diarrhea, occurring in fewer than 5% of patients and at similar rates to placebo.

Expanding Patient Access Through Clinical Research

With GEMTESA set to launch in the U.S. in early 2021, the medication brings a new therapeutic alternative for adults living with the disruptive symptoms of OAB. Dr. Fischman’s participation in this pivotal trial highlights the essential role of community-based research in making new treatments available.

DelRicht Research is proud to partner with investigators like Dr. Fischman to accelerate innovation and improve access to cutting-edge care for patients nationwide.

Read the full press release on GlobeNewswire.