FDA Rejects the Erectile Dysfunction Cream Vitaros Again

Ten years after it was first turned down by the FDA, Apricus’ topical erectile dysfunction drug Vitaros has been turned down again, pushing its shares so far down that they’re nearly penny stocks now.

The stock had been rising in the days leading up to the decision, with the hope that the FDA would approve the erectile dysfunction cream.

The problem with the erectile dysfunction cream

According to Apricus, the San Diego-based biotech company behind Vitaros, the FDA wasn’t happy enough with the chemistry, manufacturing and control elements of the marketing application, or the safety of it.

The 2.5% alprostadil cream has lost some favor over the years as oral erectile dysfunction drugs, such as Cialis, have gained popularity. Alprostadil was used as an injectable vasodilator for erectile dysfunction for decades, but the topical formulation hasn’t passed muster with the FDA

With the bad news from the FDA, Apricus is suffering financially, holding just $8.5 million in cash reserves by the start of the fourth quarter in 2017. For now, Apricus’ CEO says they’re trying to determine the company’s next move. “We are assessing the content of the complete response letter with our regulatory experts, including the information that may be needed to resolve the deficiencies and the time it would take to obtain such information with the goal of providing the market an update on our assessment in early March of this year.”

An erectile dysfunction drug that’s already approved

While you’re holding your breath waiting to see if Vitaros will ever get approved for erectile dysfunction, consider trying Cialis for your erectile dysfunction. The FDA-approved erectile dysfunction drug is one of the most popular in the world and works for more than 80% of men with erectile dysfunction.

As with any erectile dysfunction drug, it does come with possible side effects and there are some medications that can interact with Cialis, so you’ll need to discuss all your concerns and medical history with your doctor.