{"id":19080,"date":"2018-03-22T08:00:22","date_gmt":"2018-03-22T15:00:22","guid":{"rendered":"https:\/\/www.accessrx.com\/blog\/?p=19080"},"modified":"2018-11-13T15:34:21","modified_gmt":"2018-11-13T15:34:21","slug":"fda-rejects-vitaros-cream-for-second-time","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/fda-rejects-vitaros-cream-for-second-time\/","title":{"rendered":"FDA Rejects Vitaros Cream for Second Time"},"content":{"rendered":"

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.\u00a0<\/em><\/p>\n

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The Food and Drug Administration\u2019s recent rejection of Vitaros, a topical cream designed to treat erectile dysfunction, sent Apricus Biosciences<\/a> into a tailspin.<\/p>\n

Apricus is the San Diego-based biopharmaceuticals company that seeks to market the drug in the United States.<\/p>\n

The FDA\u2019s 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.<\/p>\n

In the FDA\u2019s Complete Response Letter, the agency cited deficiencies related to the drug\u2019s Chemistry, Manufacturing, and Control (CMC), as well as concerns about the safety of one of the drug\u2019s ingredients. That ingredient, known as DDAIP hydrochloride, is designed to speed absorption of alprostadil, Vitaros\u2019s active ingredient, through the skin and into the bloodstream.<\/p>\n

Richard W. Pascoe, chief executive officer of Apricus, expressed disappointment<\/a> at the FDA\u2019s decision \u201cgiven the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission.\u201d He said the company hoped to announce in early March what, if any, its next steps might be.<\/p>\n

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.<\/p>\n

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\u2019s Erection Dysfunction page<\/a>.<\/p>\n

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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.\u00a0   The Food and Drug Administration\u2019s recent rejection of Vitaros, a topical cream designed to treat erectile dysfunction, sent Apricus Biosciences into a tailspin. Apricus […]<\/p>\n","protected":false},"author":1,"featured_media":23740,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_autoblog_aioseo_focus_keyphrase":"","_autoblog_aioseo_title":"","_autoblog_aioseo_description":"","footnotes":""},"categories":[20],"tags":[23],"class_list":["post-19080","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-erectile-dysfunction","tag-erectile-dysfunction-2"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t