Phase II data: Investigational OAB agent safe, efficacious

May 21, 2012

In phase II results presented here yesterday, the investigational beta3-adrenoceptor agonist solabegron yielded statistically significant improvements in symptoms of overactive bladder compared to placebo and was safe and well tolerated, Dutch researchers reported.

In phase II results presented here yesterday, the investigational beta3-adrenoceptor agonist solabegron yielded statistically significant improvements in symptoms of overactive bladder compared to placebo and was safe and well tolerated, Dutch researchers reported.

The multicenter randomized, double-blind, placebo-controlled parallel-group study compared solabegron, 50 mg and 125 mg, to placebo in 258 women with moderate to severe OAB symptoms (averaging 4.5 incontinence episodes per day), more than half of whom had unsuccessful prior treatment with muscarinic agents. Solabegron, 125 mg, dosed twice daily over 8 weeks, produced a 66.5% reduction from baseline in incontinence episodes, a statistically significant adjusted mean difference from placebo of 25% (p=.025).

Patients treated with the agent also reported a significant reduction in the frequency of urination (−0.8, p=.036) and a marked and significant increase in the volume of urine voided (+27%, p

Adverse events did not differ between the placebo and active treatment groups. Headache and nasopharyngitis were the most frequently reported adverse events across treatment groups, with no notable changes in any cardiovascular parameters measured by 24-hour ambulatory blood pressure, clinical chemistry, hematology, or ECG parameters. Urinary retention was not observed.

"Solabegron is efficacious, safe, and well tolerated in the treatment of patients with OAB," reported the study authors, led by Martin C. Michel, MD, PhD, of Academic Medical Centre of the University of Amsterdam, Amsterdam, the Netherlands.

A phase IIb/III study of solabegron for OAB is planned to start enrolling later this year.

One of the study authors is an employee of AltheRx Pharmaceuticals, which is developing solabegron.

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