Abbott Laboratories has announced that the European Union's Committee for Proprietary Medicinal Products (CPMP) has adopted a positive opinion on Uprima sublingual for the treatment of erectile dysfunction (ED). The CPMP opinion now will be considered by the European Commission, which will make a final decision regarding the issue of a marketing authorization.
Uprima (apomorphine hydrochloride sublingual) is the first centrally acting oral therapy expected to be approved for the treatment of erectile dysfunction, a medical condition affecting an estimated 30 million men in Europe and more than 100 million men worldwide. Since Uprima is a dopamine receptor agonist, it has a centrally initiated mode of action that distinguishes it from currently available therapies. The novel sublingual formulation allows for specific stimulation of parts of the brain involved in the erectile process, thereby replicating the way the body naturally produces an erection. Its mechanism of action is distinct from other oral therapies. Uprima works through the central nervous system, producing a series of neural events, which initiate and maintain an erection.
Uprima is a small tablet that is placed under the tongue, and the drug dissolves prior to intercourse. In clinical trials, patients responding to Uprima achieved erections within 20 minutes of administration, on average. "We believe that Uprima will offer patients a convenient, first-line option for the treatment of erectile dysfunction," said William Dempsey, senior vice president, international operations, Abbott Laboratories. "The positive opinion is a major step toward making Uprima available for men affected by this disease." In clinical studies, Uprima was administered to men 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. Assessments of effectiveness were conducted by both the patients and the patients' partners.
"Erectile dysfunction is a disease that affects not only the patient, but also his partner," said Professor Udo Jonas, chairman of the department of urology at the Hannover Medical School in Hannover, Germany. "Studies of Uprima evaluated the success of erectile dysfunction therapy by collecting data from both the patient and his partner, a unique approach to clinical trials for ED." The positive opinion supports the use of 2 mg and 3 mg doses of Uprima. Studies support the concept that patients should initiate therapy with 2 mg and increase 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 in nature.