ABBOTT LABORATORIES ANNOUNCES EUROPEAN APPROVAL OF UPRIMA
NEW ORAL TREATMENT OPTION TO BE MADE AVAILABLE FOR ED PATIENTS
Abbott Park, Illinois, May 30, 2001 /PSA Rising/ - Abbott Laboratories announced today
that it has received a marketing authorization from the European Commission for
UPRIMA for the treatment of erectile dysfunction
(ED). UPRIMA (apomorphine hydrochloride) is the first centrally acting oral
therapy to be approved by the European Commission for the first-line
treatment of ED. ED is a medical condition affecting an estimated 30 million men
in Europe and more than 150 million men worldwide. UPRIMA is a small tablet that
dissolves quickly when placed under the tongue, typically producing an erectile
response in under 20 minutes.
“Every patient is different, and UPRIMA’s unique product attributes allow
physicians to provide therapy that meets the needs of individual patients,”
said William Dempsey, senior vice president, international operations, Abbott
Novel mode of action
UPRIMA is a dopamine receptor agonist that works in the brain to improve
diminished erectile function by enhancing the natural signal to the penis
following sexual stimulation, similar to the way men normally have erections.
UPRIMA works through the central nervous system, producing a series of events
that enhances the ability to achieve and maintain penile erection. It is
distinct from other oral therapies, which act by blocking the action of certain
enzymes involved in the erectile response.
Because UPRIMA is sublingually administered (under the tongue), it enters the
bloodstream quickly, bypassing the gastro-intestinal tract. The rapid absorption
of UPRIMA into the bloodstream allows for its fast onset of action, typically
under 20 minutes.
“Uprima offers several benefits for patients: it works fast, and it works
similarly to the way men normally have erections,” said Prof. Jeremy Heaton,
of Queen’s University and Kingston General Hospital, Ontario, Canada. “Long-term
data in men who continued in studies demonstrate that UPRIMA is successful in
more than 90 percent of attempts at intercourse.”
UPRIMA has been extensively studied in clinical trials involving more than
5,000 patients, with more than 120,000 doses of UPRIMA administered. UPRIMA was
studied in men with varying severity of erectile dysfunction and included
patients with organic, psychogenic or mixed etiology erectile dysfunction. The
effectiveness of UPRIMA was measured by the ability to produce an erection firm
enough for intercourse, with assessments conducted by both patient and partner
on a per-attempt basis, a unique approach in ED clinical trials.
UPRIMA treatment should be initiated at a 2 mg dose with the option of
increasing the dose to 3 mg if required. In clinical trials, the most commonly
reported adverse events were nausea, dizziness and headache, which were
generally mild and transient in nature.
Abbott Laboratories holds exclusive and non-exclusive rights to UPRIMA in
markets outside the United States and Canada, having licensed the product from
TAP Pharmaceutical Products, Inc., a joint venture between Abbott Laboratories
and Takeda Chemical Industries Ltd. TAP licensed apomorphine hydrochloride
tablets (sublingual) for erectile dysfunction from Pentech Pharmaceuticals, Inc.
Abbott Laboratories is a global, diversified health care company devoted to
the discovery, development, manufacture and marketing of pharmaceuticals,
nutritionals, and medical products, including devices and diagnostics. The
company employs approximately 70,000 people and markets its products in more
than 130 countries.