Sanofi-Synthelabo launches Uroxatral in U.S. for BPH relief
LONDON, ENGLAND, November 3, 2003 -- SkyePharma announced that Sanofi-Synthelabo has launched Uroxatral (alfuzosin hydrochloride) in the U.S. market for the relief of urinary symptoms associated with benign prostatic hypertrophy (BPH), a common condition affecting middle-aged males.
Uroxatral (known as Xatral OD outside the U.S.) was approved by the FDA on 16 June, 2003. The 10 mg once-daily extended-release formulation was developed for Sanofi-Synthelabo by SkyePharma and involves SkyePharma's proprietary Geomatrix oral controlled-release delivery technology.
BPH is a common chronic condition that typically first affects males in middle age. Thereafter the incidence rises steeply with age. Gradual enlargement of the prostate gland causes progressive obstruction of the urethra. Patients feel the need for frequent micturition but this results in incomplete emptying of the bladder. The urinary symptoms of BPH affect 22% of men aged 50-59 but 45% of men aged 70-80.
Alfuzosin is not a primary treatment for enlarged prostate but addresses the urinary symptoms by selectively blocking alpha-1 adrenergic receptors in smooth muscle of the urinary tract, causing smooth muscle in the bladder neck and prostate to relax and thereby improving urine flow. Extensive clinical studies conducted by Sanofi-Synthelabo have demonstrated that alfuzosin has a high degree of selectivity for urinary tract smooth muscle, resulting in a low incidence of vasodilatory side-effects such as postural hypotension and syncope (fainting) that can affect patients treated with competing less selective alpha blockers.
In addition alfuzosin has a low risk of sexual side-effects whereas impotence and ejaculatory disorders are well-recognized side-effects of some other alpha-blockers (and also of alternative treatments for BPH). Alfuzosin is also in late-stage clinical trials for a second related indication, acute urinary retention. Alfuzosin is the only alpha-1 blocker that has been shown in clinical trials to result in a significant decrease in post-void residual urine volume, a known risk factor for acute urinary retention.
Posted: November 2003