Vibegron (RVT-901/MK-4618/KRP-114V) Administered Once Daily as Monotherapy or Concomitantly with Tolterodine in...

Area of Science:

• Pharmacology
• Urology
• Clinical Trials

Background:

• Antimuscarinic drugs for overactive bladder (OAB) offer limited efficacy and cause side effects.
• The therapeutic potential of vibegron, a β3-adrenergic receptor agonist, for OAB remains unexplored.

Purpose of the Study:

• To assess the efficacy of once-daily oral vibegron in patients with OAB.
• To evaluate the safety, tolerability, and efficacy of vibegron, both as monotherapy and in combination with tolterodine.

Main Methods:

• A Phase IIb, randomized, double-blind, placebo-controlled trial involving 1395 OAB patients aged 18-75.
• Patients received daily oral vibegron (3, 15, 50, or 100 mg), tolterodine extended-release 4mg, or placebo for 8 weeks, with a combination arm (V50/TER4) for 4 weeks.
• Primary outcome: change in average daily micturitions at week 8; secondary outcomes: changes in urge incontinence, total incontinence, and urgency episodes.

Main Results:

• Vibegron doses of 50 mg (V50) and 100 mg (V100) significantly reduced average daily micturitions compared to placebo (-0.64 and -0.91, respectively; p<0.007).
• Both V50 and V100 significantly decreased urge incontinence episodes (-0.72 and -0.71, respectively; p<0.001).
• Vibegron was well tolerated across all doses; dry mouth incidence was lower than with tolterodine extended-release.

Conclusions:

• Once-daily vibegron (50 mg and 100 mg) effectively improves overactive bladder symptoms.
• Vibegron is well-tolerated as monotherapy and in combination with tolterodine.
• Further clinical development of vibegron for OAB is warranted.