New erectile dysfunction drug in the pipeline

Apricus Biosciences Inc. has entered into an exclusive license agreement with Takeda Pharmaceuticals International, to market Vitaros, a treatment for erectile dysfunction in the UK. The marketing authorization application for Vitaros, was accepted by the European Medicines Agency (EMA) for review in June 2011 and the license is anticipated in 2013.

European health regulators approved a marketing application for Vitaros last year. According to market researcher IMS Health, the erectile dysfunction (ED) market in the U.K. was valued at 202 million euros in 2011.

“We look forward to expanding the reach of our Vitaros product for erectile dysfunction in the U.K., the second largest ED market inEurope”, Apricus’ chief executive Bassam Damaj said in a statement.

Apricus say that, “Vitaros is a topically delivered formulation of alprostadil delivered with Dodecyl 2-N, N-(dimethylamino)-propionate hydrochloride (DDAIP HCl), Apricus’ proprietary NexACT delivery technology, for the treatment of erectile dysfunction.

When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. The NexACT technology is designed to enhance the delivery of an active drug, to improve therapeutic outcomes and cut down systemic side effects, associated with oral and injectable medications.

Vitaros has received marketing authorization in Canada and is being marketed by Abbott Laboratories Ltd. In theUSA, commercial rights to Vitaros have been licensed to Warner Chilcott. Agreements have also been signed with Sandoz-Novartis in Germany, Bracco inItaly, Elis Pharmaceuticals in certain Middle East, and Neopharm inIsraelfor marketing the erectile dysfunction therapy.

This application for Vitaros to the EMA comes hot on the heels of Stendra (avanafil), which received approval inAmericafrom the Food and Drug Administration (FDA). Stendra is the latest in line to try and steal Viagra’s crown as the best selling erectile dysfunction drug, however whilst Stendra has been approved in America, it has yet to receive approval in the UK and Europe.

Currently in the UK we have available Viagra, Cialis and Levitra, which are approved for the treatment of erectile dysfunction. Here at Medical Specialists, we have helped many men suffering from erectile dysfunction through our discreet, online consultation process. One thing for sure is, if the likes of Stendra and Vitaros receive approval in the UK in the coming years, then we here at Medical Specialists will be stocking it, to provide our patients with the widest choice and range of erectile dysfunction drugs.

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