Currently, the U.S. Food and Drug Administration (FDA) has approved vibegron or Gemtesa, which is taken daily once in the form of capsules and acts as beta-3 (β3) adrenergic receptor agonist for the management of overactive bladder (OAB) symptoms in patients suffering from benign prostatic hyperplasia (BPH). This is the first time a β3 agonist has been approved for this dual purpose offering a new hope for men with both disorders. This discovery brings the promise of relief to millions of men suffering from this illness.
Based on the approved data from the pivotal COURAGE trial (URO-901-3005): Phase III, randomized, double-blind, multicenter placebo-controlled trial. The trial included 1105 male patients older than 45 years with OAB symptoms and BPH’s pharmacological treatment including alpha-blocker monotherapy or alpha-blockers in combination with 5- alpha-reductase inhibitors (ARIs). Patients were then randomized to receive either vibegron at a dose of 75mg taken daily once or a placebo for 24 weeks. The two principal measures of efficacy in this trial were the primary objective measures of the trial: the absolute reduction in average micturition (urination) episodes per day and the absolute reduction in average urgency episodes per day at 12 weeks. Secondary objectives were to evaluate the decrease in nocturia episodes, urinary urgency incontinence (UUI) episodes, and international prostate symptom score (IPSS).
According to the outcomes of the COURAGE trial, vibegron had a statistically relevant improvement in both the co-primary outcomes when compared to the placebo. In comparison with the baseline, on the 12th week, the patients on vibegron therapy reported a decrease in average frequency and urgency of micturition by -2.04 (p < 0.001) and -2.88 (p < 0.001) episodes, respectively. On the other hand, the placebo group had changes of -1.30 and -1.93 episodes respectively. These changes were also statistically significant as evidenced by the p value of less than 0.0001.
Additional subgroup analysis showed that vibegron also decreased the frequency of nocturia per night (-0.88 vs -0.66 of placebo; p = 0.0015) and UUI episodes per day (-2.19 vs -1.39 of placebo; p = 0.0034). Further, the IPSS scores improved, and the volume voided per micturition was greater in the vibegron-treated patients with an overall increase of 25.63 mL in the vibegron group compared with 10.56 mL in the placebo group (p < 0.0001).
The incidence of adverse events (AEs) was as follows: vibegron group 45% versus placebo group 39%. In patients receiving vibegron, 4.3% experienced at least one serious adverse event (SAE) compared with only 2.9% of patients who were on a placebo. The AEs reported by most of the patients in the vibegron group were hypertension (9.0%) compared to the placebo group 8.3%, followed by urinary tract infections 2.5% in the vibegron group compared to 2.2% in the placebo group, and Coronavirus disease (COVID)-19 4.0% in the vibegron group compared to 3.1% in the placebo group.
The approval of vibegron is a positive development in the treatment of OAB symptoms in men who are undergoing BPH therapy as there are currently no available. Before, the management of this condition was almost negligible, most of the men living with this condition continued experiencing the symptoms. Vibegron has therapeutic effects on β3 adrenergic receptors in the bladder and results in bladder muscle relaxation and overall improvement of urinary symptoms. The COURAGE trial has shown the efficacy of vibegron in reducing urinary frequency and urgency and can be an important choice for men experiencing both OAB and BPH. Because of its ability to be taken once daily and its favorable safety profile, vibegron can help improve the quality of life for these patients.
The approval of vibegron (Gemtesa) by the FDA as the first and only β3 agonist for the OAB symptoms in men with BPH under pharmacological treatment is a great achievement in the management of these conditions. With these clinical studies, vibegron has demonstrated efficacy in the reduction of important OAB-related symptoms including urinary frequency and urgency, and an enhancement of the patients’ quality of life. Due to its relatively safe profile and ability to fill a treatment gap previously left unaddressed, vibegron is a promising candidate for improving the prognosis of millions of men with OAB associated with BPH.
References:
- Halpern L. FDA approves vibegron for men with overactive bladder symptoms receiving therapy for benign prostatic hyperplasia. Pharmacy Times. Updated December 23, 2024. Accessed December 26, 2024. https://www.pharmacytimes.com
- Clarke H. FDA approves vibegron for OAB symptoms in pharmacologically treated BPH. Urology Times. Updated December 23, 2024. Accessed December 26, 2024. https://www.urologytimes.com/view/fda-approves-vibegron-for-oab-symptoms-in-pharmacologically-treated-bph
