The study occurred in two parts. In Part 1, patients were equally randomized to receive: once-daily vibegron (3 mg, 15 mg, 50 mg or 100 mg); tolterodine extended release 4 mg/day (Tol4); vibegron 50mg + Tol4, or placebo for 8 weeks. In Part 2, patients were randomized 2:2:2:1 to 4 weeks of once-daily vibegron 100 mg, Tol4, vibegron 100 mg + Tol4, or placebo. If the patient completed part 1 or 2, they had the option of completing a 1 year blinded safety extension, using tolterodine as the active control.
1324 patients (94.9%) completed Part 1 or Part 2 of the trial; 845 patients elected for the 1 year safety extension study, and 78.1% have completed it to date. The authors report that patients had a statistically significant decrease in the number of daily voids, urgency and urge incontinence, with both the 50 and 100 mg dosing, when compared to tolterodine. The authors highlight that the drug was well tolerated, with a very low incidence of dry mouth. No deaths or drug related SAE’s were reported. In addition, there was no discontinuation due to hypertension but admit that this finding could change with longer follow up. Phase 3 trials have been initiated for this drug.
This study was funded by Merck & Co., Inc.
Presented By: H. David Mitcheson, MD¹
Co-Authors: Tara Frenkl MD², Suvajit Samanta PhD², Cathy Anne Pinto PhD², Stuart Green MD², Nate Bennett PhD³ and Paul Mudd Pharm D, MBA³
1. Bay State Clinical Trials
2. Merck & Co., Inc., Kenilworth, NJ
3. Roivant Sciences, Inc. on behalf of Urovant Sciences, Inc., a wholly-owned member of the Roivant family of companies, New York, NY.
Written by: Cristina Palmer, DO. Female Urology, Pelvic Reconstruction, Voiding Dysfunction Fellow, Department of Urology, UC Irvine Medical Center, Orange, California at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting (SUFU 2018), February 27-March 3, 2018, Austin, Texas