FDA Approved Drugs » 2003
Medical Areas: Nephrology | Oncology | Family Medicine | Urology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved June 2003
Treatment Area: Benign Prostatic Hyperplasia
UroXatral (alfuzosin HCl extended-release) tablets belongs to a
class of drugs called alpha-blockers. It is used in adult men to
treat the symptoms of benign prostatic hyperplasia (BPH). UroXatral
may help to relax the muscles in the prostate and the bladder,
which may lessen the symptoms of BPH and improve urine flow.
UroXatral is indicated for the treatment of the signs and
symptoms of benign prostatic hyperplasia. This drug is not
indicated for the treatment of hypertension.
The active ingredient, 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; it is currently
marketed in 14 countries in Europe and in more than 35 other
FDA approval is based on three randomized placebo-controlled,
double-blind, parallel-arm, 12-week studies. The studies enrolled
1,608 subjects of which 473 subjects received UroXatral 10 mg
daily. The pharmacokinetics of UroXatral have been evaluated in
adult healthy male volunteers after single and/or multiple
administration with daily doses ranging from 7.5 mg to 30 mg, and
in patients with BPH at doses from 7.5 mg to 15 mg.
The International Prostate Symptom Score (IPSS, or AUA Symptom
Score) consists of seven questions that assess the severity of both
irritative (frequency, urgency, nocturia) and obstructive
(incomplete emptying, stopping and starting, weak stream, and
pushing or straining) symptoms, with possible scores ranging from 0
to 35. Results showed a statistically significant reduction from
baseline to last assessment (Week 12) in the IPSS versus placebo in
all three studies, indicating a reduction in symptom severity. The
second efficacy variable was peak urinary flow rate. Peak urinary
flow rate increased statistically significantly from baseline to
last assessment (Week 12) versus placebo in studies 1 and 2. Mean
total IPSS decreased at the first scheduled observation at Day 28
and mean peak flow rate increased starting at the first scheduled
observation at Day 14 in studies 2 and 3 and Day 28 in study 1.
Adverse events associated with the use of UroXatral may include
(but are not limited to) the following:
UroXatral (alfuzosin HCl extended-release) is a selective
antagonist of post-synaptic alpha1-adrenoreceptors, which are
located in the prostate, bladder base, bladder neck, prostatic
capsule and prostatic urethra. 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
symptoms of BPH.
De la Rosette JJMCH, Karthaus HFM, de Boo Th &
Debruyne FMJ (1992b) Research in ”prostatitis syndromes”:
the use of alfuzosin (a new alpha-1-receptor blocking agent) in
patients mainly presenting with micturition complaints of an
irritative nature and confirmed urodynamic abnormalities. Eur
Urol 22: 222–227.
Fourcade RO. Efficiency and tolerance of
terazosine in ambulatory patients with benign prostatic
hypertrophy: comparative randomized and double-blind trial versus
alfuzosin. Prog Urol 2000; 10: 246-253.
Momtaz A, Robineau P, and Caille D, Alfuzosin
(SL77.0499-10): effects on the HERG channel stably expressed in
mammalian cell line -- comparison with tamsulosin, doxazosin,
prazosin, and terazosin. Sanofi Report 00-00329-EN-00
Roehrborn, C. G. and McConnell, J. D.
“Etiology, pathophysiology, epidemiology and natural history of
benign prostatic hyperplasia”. In Campbell's Urology.
Philadelphia, PA: W. B. Saunders Company, chapt 38, pp 1297-1330,
For additional information regarding UroXatral or benign
prostatic hyperplasia, please contact
Sanofi-Synthélabo Web Site
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