SkyePharma PLC announced that the US Food and Drug Administration (FDA) has approved Sanofi-Synthelabo's New Drug Application (NDA) for alfuzosin hydrochloride extended-release tablets, to be marketed in the US as UroXatral. The 10 mg once-daily extended-release formulation was developed for Sanofi-Synthelabo by SkyePharma and involves SkyePharma's proprietary Geomatrix oral controlled-release drug delivery technology. SkyePharma earns a royalty on Sanofi-Synthelabo's global sales of the once-daily formulation of alfuzosin.
Alfuzosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Alfuzosin selectively blocks alpha1-adrenergic receptors in the lower urinary tract. Blockade of these adrenoreceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow and a reduction in the symptoms of BPH. BPH is a very common disorder, leading to urinary symptoms of varying severity. The resulting symptoms affect 22% of men aged 50-59 years, but up to 45% of men aged 70-80 years. These symptoms may have an impact on men's day-to-day activities and may ultimately lead to serious complications such as acute urinary retention.
Clinical efficacy data for alfuzosin from placebo-controlled trials have demonstrated efficacy compared to placebo in urinary flow improvement and in improvement in urinary symptoms without the need for dose titration. In the clinical trials, the most common side effects occurring more frequently than placebo were dizziness, upper respiratory tract infection, headache and fatigue.
Alfuzosin is marketed in more than 80 countries throughout Europe, Latin America, Africa and Asia. Outside of the United States, the once-daily formulation (Xatral OD) is registered in 70 countries worldwide and is currently marketed in 14 countries in Europe and in more than 35 other countries. Total sales of alfuzosin reached 182 million euros in 2002 and 49 million euros in the first quarter of 2003.
Sanofi-Synthelabo has indicated that the launch of UroXatral in the United States will occur in the second half of 2003.