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news.Apricus Biosciences has appointed a manufacturer for Vitaros, its new treatment for erectile dysfunction (ED), which was approved for marketing by Health Canada on 12 November 2010.
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Specifically, the Therapex Division of E-Z-EM Canada, a wholly-owned subsidiary of Bracco Pharma in Italy, will manufacture the product for Apricus Bio.
Apricus said Therapex will also be the designated manufacturer when Apricus Bio files for marketing approval in Europe for Vitaros, which is expected in the first half of 2011.
The company intends to move forward with production of Vitaros in parallel to ongoing partnering discussions, in order to accelerate the planned commercial launch of the drug.
Vitaros, which contains a previously marketed ED drug, known by the chemical name of alprostadil, differs from other existing ED drugs like Viagra, Cialis and Levitra, Apricus said. It is applied directly to the penis as a cream, instead of as a pill that is absorbed systemically.
When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. Clinical studies have shown that Vitaros works in a matter of minutes, compared to a reported onset time of 30 minutes or more for oral medications indicated for the treatment of ED.
Apricus incorporated alprostadil with its NexACT delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis.
Apricus president and CEO Bassam Dama said its topical application helps to reduce side effects and enables men who cannot take, or do not do well with the existing drugs, to have a patient-friendly alternative.