AltheRx Pharmaceuticals, a privately-held clinical development firm, introduced positive outcomes from its Phase II study of Solabegron in overactive bladder (OAB) towards the European Association of Urology Council in Paris. Solabegron is really a novel beta3-adrenoceptor agonist having excessive affinity and selectivity that may be in late stage clinical development for the treatment of OAB and irritable bowel syndrome (IBS).
The Phase II multi-center, randomized, double-blind, placebo-controlled, similar group studies in contrast two dosage strengths of Solabegron (50 mg and 125 mg) to placebo in 258 females with reasonable to acute OAB signs and symptoms (averaging 4.5 incontinence series each day), the rest of whom had unproductive prior therapy with muscarinic constituents. Solabegron 125 mg, dosed 2 times daily over 8 weeks, generated a 65.6 percent decline from baseline in incontinence episodes, a statistically significant modified mean dissimilarity from placebo of 21 proportions.
"These are also very positive results, particularly for individuals who found no comfort from traditional therapy," said Roger R. Dmochowski, M.D., Professor, Department of Urology Vanderbilt University Medical Center."By having novel system of action, Solabegron may provide a necessary new remedy modality in OAB that could help us strengthen patients' symptoms and standard living. Outcomes of future Phase III clinical trials are expected to further scrutinize the therapeutic advantage of this compound."
Study consequences also demonstrated that in fact Solabegron 125 mg appeared to be safe and well-tolerated. Adverse effects did not vary between the placebo and dynamic treatment groups. Migraine and nasopharyngitis were the foremost frequently reported adverse effects across treatment communities without notable changes in a cardiovascular parameters measured by 24 hour ambulatory blood pressure, clinical chemistry, hematology, or ECG attributes. The urinary system retention was not made observed.
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