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Apricus ED drug cleared in Canada

Apricus Biosciences has won Canadian approval for an erectile dysfunction drug that the US Food and Drug Administration declined to clear

Apricus Biosciences, which was known until recently as NexMed, has won Canadian approval for an erectile dysfunction (ED) drug that the US Food and Drug Administration (FDA) declined to clear for marketing.

The company said that Health Canada has approved topically applied Vitaros (alprostadil) as a first-line therapy for erectile dysfunction. Alprostadil is currently marketed for the indication in injectable and intra-urethral insert product formats. The new topical version of the drug uses Apricus' NexAct transdermal delivery technology.

Unlike oral therapies for ED, including Pfizer's blockbuster Viagra (sildenafil), the topical treatment is not contraindicated for patients taking alpha blockers or nitrate medication.

Apricus said it would "quickly finalise" its marketing strategy for Canada and would also use the Canadian approval as the basis for seeking approval in over 100 other international markets. The company said recently that it is in late-stage partnership talks regarding the drug in Canada and various other markets.

Apricus plans to file a Marketing Authorisation Application for the drug in Europe during the first half of 2011, and also plans near-term submissions in the Middle East and North Africa.

In the US, where Apricus has sold the product rights to Warner Chilcott, a marketing application was submitted several years ago, but the FDA declined to approve it due to the agency's concerns about potential carcinogenicity as well as other problems with the submission. The company has been working with the FDA to address the deficiencies.

The New Drug Submission in Canada also encountered significant delays. The application was submitted in February 2008, but required additions to address deficiencies in the chemistry, manufacturing and controls portions of the application package.

Apricus is also developing Femprox, a topically applied formulation of alprostadil for the treatment of female sexual arousal disorder.

16th November 2010

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