Bayer and GlaxoSmithKline (GSK) announced that following regulatory approval, they will market vardenafil, an investigational treatment for erectile dysfunction (ED), under the global trade name Levitra (vardenafil HCI).
In Canada, the Therapeutic Products Directorate of Health Canada is presently reviewing Levitra for efficacy and safety, and market authorization has not yet been obtained. Levitra, researched and developed by Bayer, will be marketed by Bayer and GSK through a worldwide co-promotion and co-development agreement that the two companies signed in November 2001.
Marketing Authorization Applications have been approved by regulatory authorities in several Latin American countries and have been submitted for regulatory review in all major regions worldwide, including Canada, the United States, Europe and Japan. “Bayer and GSK are fully committed to developing and marketing Levitra for this significantly undertreated condition,” said Dr.
Oana Petrenciuc, Director Clinical Product Development, Bayer Healthcare. “We look forward to offering Canadian physicians a product that will help their patients who experience erectile dysfunction.” The Levitra clinical development program to date has involved approximately 4,000 patients and included eight phase III trials. Data from a published pivotal phase III study demonstrated that in a broad patient population of 805 men, up to 85 per cent of patients taking Levitra reported improved erections, which was significantly different from 28 per cent in the placebo group.1 In this phase III study, drug-related adverse events were reported as generally mild to moderate in intensity with the most frequent adverse events being headache, rhinitis, flushing and dyspepsia.
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