By Brian Bujdos
Erectile dysfunction patients in Canada will soon have a convenient new option to treat their condition. The Canadian version of the U.S. Food and Drug Administration (FDA), which is called Health Canada, approved a drug called Vitaros.¬† Vitaros is a topically applied medication that was proven in clinical studies to help men perform better in bed.¬†Vitaros is manufactured by Apricus Biosciences, Inc., which sold its U.S. rights for Vitaros to a company called Warner, which has begun its own process to get FDA approval for Vitaros. ¬†Apricus stands to gain about $5 million for selling its U.S. rights to the medication. Vitaros includes the active ingredient alprostadil, a common FDA-approved vasodilator that is currently sold as an injectable medication, or as an intra-urethral insert product, to treat erectile dysfunction (see a product called Muse).
The Canadian approval for Vitaros opens up a huge window of opportunity for Apricus Biosciences, which says it will attempt to bring Vitaros to market in more than 100 additional countries. The company is finalizing its Canadian marketing plan for Vitaros and hopes to officially launch the drug in Canada next year.
The only erectile dysfunction medications that have been approved for sale in the U.S. are Viagra, Cialis and Levitra. All of these medications are taken orally as a pill. Vitaros, on the other hand, is applied directly on the penis, and scientists from Apricus say that Vitaros works within minutes. The above-mentioned, FDA-approved drugs take about a half an hour to be effective.
Another positive about Vitaros is that patients who have diabetes or heart problems can take the medication. Viagra, Cialis and Levitra cannot be taken by patients who take nitrates or alpha blockers, because those medications can cause a drop in blood pressure that could¬† be harmful or even fatal. But that is not the case with Vitaros., which was proven to be effective in studies involving more than 3,300 patients, including patients who had undergone a prostatectomy. Vitaros was both effective and safe in the studies.
In terms of Warner‚Äôs efforts to get Vitaros approved in the U.S., the company submitted a CAC assessment package to the FDA in the fourth quarter of 2009. Although discussions have been ongoing with the FDA, there was nothing new to report in terms of the FDA‚Äôs stance on Vitaros in early November.
The¬†Canadian approval of the drug can only help its chances, however the FDA is often more stringent with clinical study results before allowing drugs to reach the U.S. market. Stay tuned for more.¬†In other news for topical treatments for erectile dysfunction, a low-testosterone medication called Testim has also proven to be effective for men with erectile dysfunction. Researchers from the Baylor College of Medicine stated this week that Testim is not only effective for men with hypogonadism (low testosterone), it also improved the sexual performance of men with erectile dysfunction.
“Historically testosterone replacement therapy was thought to only improve libido or sexual desire, which is very different from sexual function,” said Dr. Mohit Khera, the study’s leader. But Testim can apparently also help men with ED, according to the new study, which involved a small participant base of 42 men.
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