General Information

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.

Mechanism of Action

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.

Side Effects

Adverse events associated with the use of UroXatral may include (but are not limited to) the following:

• upper respiratory tract infection
• headache
• fatigue
• pain
• impotence

Dosing/Administration

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 countries.

Clinical Trial Results

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.