Novartis Pharma AG announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending that the European Commission (EC) grant a marketing authorisation for Emselex (darifenacin hydrobromide), 7.5mg and 15mg, for the treatment of overactive bladder (OAB) in all 25 European Union (EU) countries as well as Norway and Iceland. Upon receipt of the EC approval, Novartis will be able to market Emselex these countries.

The CHMP based its positive opinion on Emselex's comprehensive data package for OAB. The safety and efficacy of Emselex has been extensively studied in over 90 pre-clinical studies and clinical trials, involving more than 5,000 patients. Pivotal studies explored key endpoints including the reduction in the number of incontinence episodes per week, the reduction in the number of voluntary urination episodes (micturition) per day, the reduction in the episodes and severity of urgency and an increase in the average volume of urine passed per micturition.

The phase III clinical trials demonstrated the efficacy, safety and tolerability of Emselex. A pooled analysis of three multi-centre, double-blind, placebo-controlled studies included a population of 1,049 adults with OAB symptoms for more than 6 months.

Results demonstrated that Emselex reduces the number of weekly incontinence episodes by up to 77 per cent. Emselex was well tolerated and discontinuation rates due to dry mouth or constipation were very low with each dose of Emselex compared to placebo. Also, central nervous system (CNS) and cardiovascular safety of Emselex were comparable to placebo at both doses1. Another study showed Emselex does not impair cognitive function such as memory, choice reaction time and word recognition, compared to placebo.

"We are delighted by the CHMP's positive opinion for Emselex, to provide overactive bladder sufferers with a new safe and effective treatment option," said Jorg Reinhardt, global head of Development Novartis Pharma AG. "Due to its M3 selectivity, Emselex provides effective overactive bladder symptom relief while decreasing the potential risk of safety issues such as cognitive impairment or effects on cardiac function," he added.

OAB affects almost one in six adults in Europe. Symptoms of overactive bladder are urinary urgency (a sudden compelling desire to pass urine, which is difficult to differ) with or without urge incontinence (involuntary leakage accompanied by urgency), urinary frequency (voiding the bladder too often), and nocturia (waking at night one or more times to void the bladder).