PARIS, FRANCE (UroToday.com) - The phase 2 solabegron study results demonstrate it is safe, well tolerated, and effective for improving symptoms of overactive bladder.
Solabegron, a novel beta-3 adrenoceptor agonist with high affinity and selectivity, is in clinical development for the treatment of patients with overactive bladder. A Phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study was performed to evaluate the safety and efficacy of oral solabegron in 258 women with OAB symptoms.
Subjects were enrolled to receive solabegron 50 mg, 125 mg, or matching placebo twice daily for 8 weeks. Based on a 3-day electronic diary, patients with ≥8 micturitions/24 hours, and ≥1 incontinence episodes/24 hours, and ≥1 urgency episodes /24 hours were randomized to double-blind treatment. Percent change from baseline to week 8 in the number of incontinence episodes over 24 hours was the primary endpoint.
In this patient population, the mean baseline for incontinence episodes was 4.5 episodes/24hr. For the primary endpoint, solabegron (125 mg) produced a statistically significant (65%) mean reduction from baseline in incontinence episodes and an adjusted mean difference from placebo of 21% (p=0.025). The median reduction in incontinence episodes was 75% from baseline. Solabegron produced an adjusted mean reduction from placebo in incontinence episodes for both the 50 mg (23%; p=0.03) and 125 mg (32%; p=0.003) treatment arms after 4 weeks of treatment. At the 125 mg dose, there was a significant reduction in the number of micturitions at week 4 (-0.7;p= 0.05) and week 8 (-0.8; p=0.036). There was a marked and significant increase in the volume voided per micturition at week 8 for the solabegron 125mg treatment group (+27%).
Presented by Ohlstein, EH,1 Michel, MC,2 Von Keitz, A3 at the 27th Annual European Association of Urology (EAU) Congress - February 24 - 28, 2012 - Le Palais des Congrès de Paris, Paris, France
1AltheRx Pharmaceuticals, R&D Dept., Malvern, United States of America, 2University of Amsterdam, Dept. of Pharmacology, Amsterdam, Netherlands, The, 3Urology Practice, Marburg, Germany