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A new, approved erectile dysfunction (ED) drug is one step closer to becoming a reality – but only in Canada for now. Health Canada (the Canadian version of the U.S. Food and Drug Administration), approved a first-of-its-kind drug called Vitaros last month. Vitaros is unique because it is applied to the penis as a cream, as opposed to FDA-approved Viagra, Cialis and Levitra.
The manufacture of Vitaros, Apricus Biosciences, announced this week that it has partnered with the Therapex Division of E-Z-EM Canada, Inc., a wholly-owned subsidiary of Bracco Pharma in Italy, which will soon start to manufacture the drug so that Apricus can bring the medication to the Canadian market in 2011.
Vitaros is effective due to a totally different biochemical mechanism than FDA-approved ED pills that are taken orally. Viagra, Cialis and Levitra are PDE-5 inhibitors, which relax muscles in the penis so that blood vessels can fill with blood and cause an erection.
Vitaros, on the other hand, causes an erection in a localized manner. Vitaros contains a commonly marketed ED drug with the chemical name alprostadil, a vasodilator that can directly boost blood flow and quickly cause an erection. While Viagra and its competitors take 20 or 30 minutes to become effective, Vitaros will provide results very quickly after application.
Apricus said it will attempt to bring Vitaros to market in 100 additional countries. It is uncertain how long it will take Vitaros to be available in the U.S. Apricus sold its rights to market the drug in the U.S. to a company named Warner, which submitted an assessment package to the FDA in the fourth quarter of 2009. Warner hasn’t gotten very far in its discussions with the FDA apparently, as there is no news to report.
So, right now, Vitaros is a savior only for Canadian men who may not be able to use Viagra, Cialis or Levitra, or who may not have achieved the desired results with those drugs. Vitaros has a lot of upside because it is often effective for men with diabetes and heart problems. Some medications such as nitrates and alpha blockers cannot be taken with Viagra, due to the fact they dangerously lower blood pressure.
Vitaros, however, has a very low rate of side effects, and it can be used at the same time as almost all other medications. The new drug was found to be safe and effective in clinical studies that included more than 3,300 men. Men who have prostatectomies often suffer from ED, and Vitaros was found to help some of these men.
Due to the fact Vitaros contains an active ingredient (alprostadil) that is already approved by the FDA, it only seems to reason that the FDA will eventually approve some form of Vitaros in the U.S. How long that will take, though, is anyone’s guess. There are surely many men clamoring for a less expensive version of the currently approved ED drugs. The prices of Viagra, Cialis and Levitra have skyrocketed in the last 5 to 7 years.
eDrugstore reported the Canadian approval of Vitaros last month in a separate blog entry, if you’d like to take a look.
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