(Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences Inc’s Vitaros, a cream treatment for erectile dysfunction, for the second time in a decade.
Shares fell 43 percent to $1.79 in premarket trade.
Chief Executive Officer Richard Pascoe said the company will provide an update in early March on its plans for the drug.
About 20 million men in the United States suffer from erectile dysfunction, which may stem from a physical conditions such as obesity or injury, or whose root cause is psychological.
The FDA flagged certain safety concerns related to an ingredient in the drug and identified deficiencies in its chemistry and manufacturing, the company said.
The ingredient, DDAIP.HCl, helps in the absorption of skin products.
Outside of the U.S., Vitaros has been on the market since 2012 and is sold in Canada, Mexico, parts of the Middle East and much of Europe by Apricus’ commercial partner, privately held Ferring International Center S.A.
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