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Already available in several European countries, Vitaros is a topical cream that purportedly works quickly to overcome symptoms of erectile dysfunction. Its path toward possible approval in the United States hit a stumbling block in February 2018 when the Food and Drug Administration rejected the new drug application for Vitaros submitted by Apricus Biosciences. But all hope is not yet lost.
The medication combines alprostadil, a powerful vasodilator, with a chemical compound, DDAIP hydrochloride, that facilitates rapid absorption of the drug through the skin of the penis. FDA’s problem with Apricus’s latest bid for Vitaros has nothing to do with its alprostadil ingredient, a drug already widely used in penile injection therapy and as a transurethral suppository. Rather the drug regulatory agency is concerned about the high concentration — 2.5 percent — of DDAIP used in Apricus’s formulation for Vitaros.
FDA Outlines Changes It Wants
In its end-of-review meeting with Apricus, FDA said that the concentration of DDAIP in Vitaros would have to be reduced from 2.5 percent to 0.5 percent if it were to win approval. The reformulated version of Vitaros would then have to undergo two new late-stage studies to confirm both its efficacy and safety. There’s just one problem, says Apricus. It simply lacks the financial resources to do what the FDA says is needed to win approval.
Because it lacks the wherewithal to reformulate the medication and conduct time-consuming and costly clinical trials, Apricus is looking for a drugmaker with deeper pockets to purchase the U.S. rights to Vitaros and take over the costly campaign to win FDA approval. As of this writing, there have been no takers.
For now, the treatment of choice for men with erectile dysfunction is the family of oral medications known as PDE5 inhibitors. These include Viagra, Levitra, Cialis, Staxyn, and Stendra, as well as generic Viagra that is sold as sildenafil citrate.
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