Sanofi-Synthélabo
launches UROXATRAL®
in the United States
for effective relief
of the signs and symptoms
of enlarged prostate
Sanofi-Synthelabo announced today
that Uroxatral® (alfuzosin hydrochloride extended-release tablets) has been launched
in the United States. Uroxatral® is a new 10 mg, once-daily prescription
alpha1-blocker that provides effective relief of the signs and symptoms of
benign prostatic hyperplasia (BPH).
The launch of Uroxatral® further
expands Sanofi-Synthelabo’s key strategic product portfolio and establishes the
company’s commitment to building its internal medicine franchise.
Uroxatral® exhibits selectivity
for alpha1-adrenergic receptors in the lower urinary tract(1).
Uroxatral® works by relaxing the muscle surrounding the prostate, bladder neck and
prostatic urethra to effectively treat the symptoms of BPH – a non-cancerous
enlargement of the prostate. Symptoms can include a frequent or urgent need to urinate,
hesitancy in urinating and reduced urinary flow.
In three clinical trials,
Uroxatral® demonstrated a statistically significant reduction in prostate symptoms
severity versus placebo at the last assessment (week 12)(1). Uroxatral®
showed an improvement in peak urine flow rate versus placebo at last assessment (week 12)
(1).
“Men who are trying to cope with
bothersome and noticeable symptoms should know that urinary problems may not necessarily
be a part of aging. The symptoms related to benign enlargement of the prostate can be
effectively treated with Uroxatral®, which can bring much needed relief to the
millions of men suffering from bothersome urinary problems,” said Claus G. Roehrborn,
MD, Professor and Chairman, Department of Urology, University of Texas, Southwest Medical
Center. “Rather than live with these symptoms, men should see their doctors about
treatment options and their side effect profiles. BPH treatment is sometimes associated
with sexual side effects. Sexual side effects such as ejaculatory dysfunction (EjD) and
erectile dysfunction (ED) should be considered in the management of patients
with enlarged prostate.”
“The symptoms of BPH can have a
significant impact on a man’s day-to-day activities,” added Dr. Roehrborn.
“Furthermore, left untreated, the symptoms may progress, which can lead to serious
health problems including urinary tract infections, bladder and kidney damage, bladder
stones, incontinence and acute urinary retention.”
Uroxatral® exhibits a low
incidence of vasodilatory side effects (dizziness: 5.7% versus placebo 2.8%) and a low
incidence of hypotension (0.4% versus placebo 0.0%) and syncope (0.2% versus placebo 0.0%)
(1).
Important Information
About BPH – Enlarged Prostate
Affecting more than eight million men
in the United States, BPH is a non-cancerous enlargement of the prostate, a progressive
condition that can cause urinary symptoms, such as frequent and urgent need to urinate
during the day and night, decreased urinary flow, and weak urinary stream. More than half
of all men over age 60 suffer from BPH, and after age 80 men have an 80 percent chance of
developing BPH(2). The U.S. BPH market is approaching $1 billion (IMS MAT Sales
July 2003) up 14 percent.
Important Information
About Lower Urinary Tract Symptoms And Sexual Dysfunction
In a recent multinational survey
study of nearly 14,000, lower urinary tract symptoms related to an enlarged prostate
– which affect 90 percent of men over age 50 – are strongly correlated to sexual
dysfunction. Erectile and ejaculatory dysfunction are more common in men with lower
urinary tract symptoms than in men with other conditions known to be associated with
erectile dysfunction, such as diabetes, hypertension, cardiac disease and hyperlipidemia.
Men with severe urinary symptoms reported 50 percent less sexual activity and 33 percent
reduction in overall sexual satisfaction (3).
Important Safety
Information
Uroxatral® should not be used in
patients with moderate to severe hepatic insufficiency (Childs-Pugh categories B and C),
since Uroxatral® blood levels are increased in these patients. Uroxatral® should
not be used in combination with CYP3A4 inhibitors such as ketoconazole, itraconazole, and
ritonavir. Caution should be used in patients with severe renal insufficiency (creatinine
clearance <30 mL/min). Uroxatral® should not be used in combination with other
alpha-blockers. If symptoms of angina pectoris should newly appear or worsen, the use of
Uroxatral® should be discontinued. In a study of QT effect in 45 healthy males, the QT
effect appeared less with Uroxatral® 10 mg than with 40 mg, and the effect of
Uroxatral® 40 mg did not appear as large as that of the active control moxifloxacin at
its therapeutic dose. This should be considered in clinical decisions to prescribe
Uroxatral® for patients with a known history of QT prolongation or patients who are
taking medications known to prolong QT. There has been no signal of Torsades de Pointe in
the extensive post marketing experience with Uroxatral® worldwide. There are no known
pharmacokinetic/pharmacodynamic studies of the effects of other alpha-blockers on cardiac
repolarization.
Carcinoma of the prostate and BPH
cause many of the same symptoms. These two diseases frequently coexist. Therefore,
patients thought to have BPH should be examined prior to starting therapy with
Uroxatral® to rule out the presence of carcinoma of the prostate. Postural hypotension
with or without symptoms may develop within a few hours following administration of
Uroxatral®. As with all alpha-blockers, there is a potential for syncope. Patients
should be warned of the possible occurrence of such events and should avoid situations
where injury could result should syncope occur. In clinical trials, the most common side
effects occurring in > 2% of patients and more frequently than placebo were
dizziness (5.7% versus 2.8%), upper respiratory tract infection (3.0% versus 0.6%),
headache (3.0% versus 1.8%), and fatigue (2.7% versus 1.8%)(1).
About Sanofi-Synthelabo
Sanofi-Synthelabo is a major global
research-based pharmaceutical group with 32,500 employees in more than 100 countries. The
company is headquartered in Paris and listed in Paris (Euronext : SAN) and in New York
(NYSE : SNY). With consolidated sales of EUR 7.4 billion in 2002, Sanofi-Synthelabo ranks
7th in Europe and among the world’s top 20 pharmaceutical companies. With an R&D
portfolio of 55 compounds in development, Sanofi-Synthelabo is focused on a core group of
four therapeutic areas: cardiovascular disease and thrombosis; diseases of the central
nervous system; internal medicine; and oncology.
Full prescribing information for
Uroxatral is available at www.uroxatral.com.
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