Topical ED Treatment Vitaros Approved in Europe

Megan Brooks


June 10, 2013

Apricus Biosciences has received European approval to market alprostadil 0.3% topical cream (Vitaros) for the treatment of erectile dysfunction (ED), the company announced today.

Vitaros is a topically applied cream formulation of the vasodilator alprostadil combined with a proprietary permeation enhancer that increases blood flow to the penis, causing an erection, the company said.

Vitaros is already approved in Canada.

On May 7, during the American Urological Association Annual Meeting, John P. Mulhall, MD, director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center in New York City, presented safety and efficacy data from a phase 3 study of Vitaros in 325 men with ED that was previously unresponsive to phosphodiesterase type 5 (PDE-5) inhibitors.

Results showed that Vitaros improved erections in this population and that adverse events were mild to moderate, similar to those seen in the control group, and decreased with repeated exposure, the company said.

"PDE-5 inhibitors, while effective, address only a portion of the ED patient population. In the current treatment landscape, this leaves a large population of unresponsive or contraindicated patients with few or no alternatives," Dr. Mulhall said in a statement.

"Vitaros utilizes a novel mechanism of action that has demonstrated successful ED therapy without the side effects associated with current products, making it an effective and practical option for these patients," added Dr. Mulhall, associate editor for the Journal of Sexual Medicine and past president of the Sexual Medicine Society of North America.

In Europe, Vitaros was approved through a European Decentralized Procedure (DCP).

Under the DCP, Apricus Biosciences filed its application for marketing approval designating Netherlands as the reference member state on behalf of 9 other European concerned member states participating in the DCP, the company explains. The other concerned member states include France, Germany, Italy, the United Kingdom, Ireland, Spain, Sweden, Belgium, and Luxembourg.


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