Urovant Sciences (Irvine, California) is upbeat about the prospects of beta-3 adrenergic receptor agonist Gemtesa (vibegron) in treating overactive bladder (OAB). This week, the drug was featured in two presentations at the virtual American Urological Association (AUA) Annual Meeting.
Historically, the primary treatment for OAB involved a type of anticholinergics known as muscarinic receptor antagonists.
In 2012, Astellas Pharma (TYO: 4503) won FDA approval for Myrbetriq (mirabegron), the first beta-3 adrenergic receptor agonist for OAB to hit the market. More recently, Urovant, a subsidiary of Sumitovant Biopharma Ltd., won FDA approval for Gemtesa (vibegron), another beta-3 adrenergic receptor agonist, which became commercially available in April.
Anticholinergics used for OAB can have bothersome side effects such as dry mouth and constipation, said Dr. Cornelia Haag-Molkenteller, chief medical officer at Urovant. Such side effects lead many patients to discontinue treatment.
Beta-3 agonists are overall better tolerated than anticholinergics. “Their improved safety profile is an important differentiator to anticholinergics,” Haag-Molkenteller said.
In addition, research indicates that prolonged use of anticholinergics may increase the risk of cognitive impairment and dementia. A 2019 JAMA study found significant “increases in dementia risk” for patients taking bladder antimuscarinic drugs.
Dr. Cornelia Haag-Molkenteller
One potential concern regarding beta-3 agonists such as vibegron is that they could elevate blood pressure. But data recently presented at the annual meeting of the American Urological Association found no blood pressure elevation among vibegron recipients over the 28-day study period. “At the end of the 28-day treatment period, there was no difference in the effect of vibregon versus placebo on systolic or diastolic blood pressure, or heart rate,” Haag-Molkenteller said.
A separate poster presentation at the event supported the efficacy of vibegron in patients with “dry” overactive bladder (without urinary leakage). That presentation drew from a posthoc analysis from the pivotal EMPOWUR trial.
“It’s important for doctors also to see that [vibegron] also works in those people who have overactive bladder but are not yet wetting themselves,” Haag-Molkenteller said.
While vibegron has only been on the U.S. market for about six months, Haag-Molkenteller said a growing number of doctors are becoming wary of anticholinergics — “especially in people with the risk of dementia.” “The risk of this dementia with the anticholinergics with chronic treatment cannot be underestimated,” she continued. “There are now two beta-3’s on the market. I think they offer a good treatment alternative.”