Erectile Dysfunction Cream Rejected by FDA Again

Feb. 16, 2018

The FDA has once again rejected a cream for erectile dysfunction made by Apricus Biosciences Inc.

The cream, called Vitaros, is already sold in Canada, Mexico, the EU and parts of the Middle East. But 10 years after the FDA rejected Vitaros over worries it could cause cancer in users or their sexual partners, the agency now flagged the product for safety concerns related to “chemistry and manufacturing.”

In particular, the FDA is worried about the current 2.5 percent concentration of DDAIP.HCI, which is used to aid skin absorption.

An estimated 20 million men in the U.S. suffer from ED. Although there are several oral medications on the market, they also carry side effects such as headaches and dizziness 

Apricus stated that the company is disappointed with the FDA’s decision but that it is working with the agency to “resolve the deficiencies.”

Read the full Reuters report.