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Hardly a newcomer to the treatment of erectile dysfunction, alprostadil has been used for several years in both injectable and suppository form in the United States.
Now it appears likely that it may soon become available to American consumers as a topical cream that can be applied to the penis to temporarily improve blood flow and thus facilitate erection.
Alprostadil is still the drug of choice for penile injection therapy, which involves the injection of a vasodilating drug directly into the shaft of the penis. Injection therapy has perhaps the highest success rate of all ED treatments but is shunned by those who break into a cold sweat at the thought of injecting a needle into their penis.
Alprostadil Also Used in Another Delivery System
An alternate delivery system for alprostadil is MUSE, the brand-name acronym for Medicated Urethral System for Erection. Using the MUSE system, an alprostadil suppository pellet is inserted into the urethral opening at the tip of the penis with the help of a tiny applicator. The MUSE system is not nearly as effective as penile injection therapy, studies show.
For nearly five years, alprostadil also has been available in most of Europe as a topical cream for the treatment of erectile dysfunction. This topical cream is also available in Canada. However, it has thus far failed to win approval from the Food and Drug Administration in the United States. This could change soon. In fact, as this is written, the FDA is only days from its deadline of February 17, 2018, for completion of its consideration of the new drug application for Vitaros, the proposed brand name for the topical cream.
Apricus Holds US Rights to Vitaros
Although Ireland- based Allergan PLC holds the rights to Vitaros, San Diego-based Apricus Biosciences Inc. has licensed the U.S. development and commercialization rights for the product from Allergan. Vitaros combines alprostadil, a well-established vasodilator, with a proprietary delivery agent known as NexACT that helps to speed the drug’s absorption into the penis.
In September 2007, NexMed, which at that time held the U.S. rights to Vitaros and is now a subsidiary of Apricus Biosciences, first filed for FDA approval of the medication. The following year, the drug regulatory agency rejected Nexmed’s new drug application but listed the deficiencies it had found in its consideration of Vitaros to guide the manufacturer in making changes to the product.
Revised Application Submitted
In August 2017 Apricus Biosciences submitted a revised new drug application for Vitaros, and it is on that revised submission that the FDA is scheduled to rule imminently.
In an overview of evidence produced by clinical trials of Vitaros, urologic surgeon Beatrice Cuzin, M.D., of France’s Edouard Herriot University Hospital in Lyon said tests had shown the drug was well absorbed locally with very minimal systemic effect. Furthermore, Vitaros is a form of ED treatment that is well tolerated by ED patients who don’t respond well to PDE5 inhibitors, and its adverse effects are generally mild and short-lived.
Vitaros Outperforms Placebo
Clinical studies, writes Dr. Cuzin, indicate that Vitaros (sold under the brand name Virirec in some foreign markets) significantly improved erectile function in study participants when compared to the results observed in control subjects who were treated with placebo.
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