SkyePharma PLC and Sanofi-Synthelabo have received an “approvable letter” from the US FDA for UroXatral (once-daily formulation of alfuzosin) for the symptomatic treatment of benign prostatic hyperplasia.
The formulation utilizes SkyePharma’s proprietary oral drug delivery technology, GEOMATRIX.
The New Drug Application for UroXatral was submitted in December 2000 in the United States.
Michael Ashton, SkyePharma’s CEO commented, “We are excited about the future revenue and earnings potential for Xatral OD in the U.S. following the successful launch in Europe. The once-a-day formulation utilizing Geomatrix should increase convenience and compliance, resulting in a better outcome for patients.”
Alfuzosin, a compound from Sanofi-Synthelabo research, is a uroselective alpha1-blocker marketed under the brand name Xatral throughout Europe, Latin America, Africa and Asia.
SkyePharma PLC, one of the world’s leading drug delivery companies, provides innovative services to major pharmaceutical partners from the point of drug discovery through the approval process.
Its five technologies, oral, injectable, inhalation, topical, and nanoparticulate solubilisation encompass the vast majority of delivery systems in use by the pharmaceutical industry.