FDA approves Gemtesa for overactive bladder

The FDA recently approved a new drug application for Gemtesa, a novel treatment for overactive bladder in adults, its manufacturer announced in a press release.

Gemtesa (vibegron, Urovant Sciences) helps relax the detrusor bladder muscle, enabling the bladder to hold more urine, thereby reducing symptoms of overactive bladder, according to the manufacturer.

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

The FDA’s approval of vibegron was based on data from the 12-week, double blind, placebo-controlled, phase 3 EMPOWUR study, which included more than 4,000 patients with overactive bladder. The results showed that vibegron was associated with statistically significant reductions in daily urge urinary incontinence, micturitions and urgency episodes, according to the press release.

The most common adverse events tied to vibegron use were diarrhea, headache, nasopharyngitis, nausea and upper respiratory tract infection, Urovant Sciences said in the release.

“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,” Staskin said.

Vibegron should be available in the United States late in the first quarter of 2021, Jim Robinson, president and CEO of Urovant Sciences, said in the release. He added the medication “provides a compelling alternative for the many patients suffering from the burden of an overactive bladder.”