SkyePharma PLC and Sanofi-Synthelabo announced that a New Drug Application (NDA) was filed with the U.S. Food & Drug Administration in December 2000 for Xatral OD, a sustained release once-daily formulation of alfuzosin 10mg. The formulation utilizes SkyePharma's proprietary oral drug delivery technology, Geomatrix.
Xatral is used for the treatment of the functional symptoms of benign prostatic hyperplasia (BPH), a common disorder in men over the age of 50. Xatral is available in more than 80 countries worldwide as a two or three times a day formulation. The Geomatrix formulation allows the drug to be taken once a day and will be Xatral's first introduction in the U.S.A.
Michael Ashton, SkyePharma's chief executive officer commented, "We are excited about the future revenue and earnings potential for Xatral OD in the U.S. following the successful launch of the product in Europe. The once-a-day formulation utilizing Geomatrix should increase convenience and compliance, resulting in a better outcome for patients."
Xatral OD was launched in Europe in February 2000 and is now available in six European countries and French overseas territories. In those countries, the once-daily formulation has already gained a significant proportion of Xatral sales. It is expected that other European launches of Xatral OD will follow in the near future.