Last Friday, the Federal Drug Administration (FDA) approved a new erectile dysfunction drug, Stendra, which its creators are touting as a superior alternative to Viagra. Erectile dysfunction, or the inability to keep an erection, affects more than 30 million men in the U.S., and sales of treatment drugs exceeded $5 billion last year. Here's a look at the potentially lucrative newcomer:
What is Stendra exactly?
The FDA-backed medication, known chemically as avanafil, is in the same class as drugs like Viagra, Cialis, and Levitra. All "inhibit the same enzyme, PDE5, and work by increasing blood flow to the penis," says USA Today. What separates Stendra from its competitors, however, is its ability to work 30 to 60 minutes faster than other pills. While Stendra is supposed to be taken 30 minutes before sexual activity, studies have shown that the drug can work in as little as 15 minutes. "You can argue this is the first potential on-demand drug [for sex]," Dr. Irwin Goldstein, co-author of a recent study looking at Stendra's effectiveness, tells CNN.
Who makes it?
Stendra is made by a company called Vivus, Inc., based in Mountain View, Calif. The company is also responsible for the anti-obesity pill Qnexa, which is pending FDA approval. Stendra is currently Vivus, Inc.'s only product on the market.
Does Stendra have side effects?
Common side effects include headaches, redness of the face, nasal congestion, and back pain. Like Viagra and other PDE5 inhibitors, Stendra can cause "color-vision changes," and a few people have reported sudden loss of vision in one or both eyes, and also a loss of hearing, says the Wall Street Journal. The new drug "shouldn't be taken by men who take nitrates for chest pain because the combination of the two drugs can cause an unsafe drop in blood pressure."
Should Viagra's makers be worried?
Stendra will sell well, but it probably won't be a Viagra-killer. The new drug is projected to generate around $68 million in sales next year, a paltry amount when compared with Viagra's estimated $2 billion, says Bloomberg. There are actually larger concerns on the horizon for both companies: Patents for Cialis and Levitra will expire in 2016 and 2018, respectively, meaning "generic competition" is on the horizon. And non-branded Viagra is expected to hit pharmacies as soon as 2019. In short, Vivus will be "rolling a rock up a hill on the generic side," analyst Michael King tells Bloomberg.
Sources: Bloomberg, CNN, USA Today, Wall Street Journal