Vitaros, a topical cream used to treat erectile dysfunction (ED) is marketed in other countries, but will not be coming to the US any time soon due to FDA rejection.
The Food and Drug Administration’s recent rejection of Vitaros, a topical cream designed to treat erectile dysfunction, sent Apricus Biosciences into a tailspin.
Apricus is the San Diego-based biopharmaceuticals company that seeks to market the drug in the United States.
The FDA’s February 16, 2018, the decision was the second time the drug regulatory agency turned thumbs down on Vitaros, the first rejection coming nearly a decade earlier.
In the FDA’s Complete Response Letter, the agency cited deficiencies related to the drug’s Chemistry, Manufacturing, and Control (CMC), as well as concerns about the safety of one of the drug’s ingredients. That ingredient, known as DDAIP hydrochloride, is designed to speed absorption of alprostadil, Vitaros’s active ingredient, through the skin and into the bloodstream.
Richard W. Pascoe, chief executive officer of Apricus, expressed disappointment at the FDA’s decision “given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission.” He said the company hoped to announce in early March what, if any, its next steps might be.
Alprostadil is a vasodilating drug that is currently available in the United States only in injectable and suppository forms. Ferring International Center S.A., a Swiss-based commercial partner of Apricus, markets Vitaros in Canada, Mexico, most of Europe, and parts of the Middle East.
While the future of Vitaros on the U.S. market is uncertain, the best option for men with erection problems related to blood flow remains the so-called PDE5 inhibitors, including Viagra, Cialis, Levitra, Staxyn, and Stendra. If the convenience of ordering these drugs online appeals to you, consider using the services of a reputable online facilitator such as Access.Rx. To learn more, click below to visit eDrugstore’s Erection Dysfunction page.
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