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 Laboratories.

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.”

Clinical Data

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.

Source: Abbott
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June 5, 2001