Novartis Pharmaceuticals Corporation has received an approvable letter from the US Food and Drug Administration (FDA) for Enablex (darifenacin hydrobromide) for the treatment of overactive bladder. Acquired by Novartis in 2003, Enablex is an M3 selective receptor antagonist (M3 SRA), which works by selectively blocking an important receptor involved in the control of bladder muscle contraction. Novartis expects to launch the drug in 2004 after completing a limited amount of additional clinical work requested by FDA.
"Overactive bladder greatly impacts a person's ability to live a normal life. Sufferers often limit travel, social and work activities to avoid embarrassing situations that the condition can cause. Many patients go untreated, whilst those who do seek treatment are often unsatisfied with their medication," commented Joerg Reinhardt, Global Head of Development at Novartis.
The safety and efficacy of Enablex has been extensively studied in numerous pre-clinical studies and more than 90 clinical trials involving more than 5,000 patients. Pivotal studies explored key endpoints including the number of incontinence episodes per week, voluntary urination episodes (micturations) per day, episodes of urgency and average volume of urine passed per micturation.
It is estimated that more than 17 million Americans experience bladder control problems, of which urge incontinence or overactive bladder is one of the most common. Caused by a problem with the bladder's detrusor muscle, overactive bladder is characterized by incontinence, urinary urgency and frequency, and nocturia (awakening at night to urinate). According to the American Foundation for Urologic Diseases, at least 16 percent of the population over the age of 40 suffer from chronic and troublesome symptoms of an overactive bladder. Although prevalence increases with age, the problem affects people of all ages, a large number of whom are under 65. As many as 30 to 50 percent of women over 50 are estimated to suffer from the condition. In many patients, a specific cause for the symptoms cannot be identified. As the population becomes increasingly older, the need and hence the market for safe and effective treatments continues to grow.
In clinical trials, the most commonly reported side effects in Enablex- treated patients were dry mouth and constipation; however, the patient discontinuation rates due to these events were low.