New Erectile Dysfunction Drug Approved

On April 27, pharmaceutical manufacturer Vivus announced the approval of its erectile dysfunction (ED) drug, Stendra (generic name avanafil) by the US Food and Drug Administration. It is the first ED medicine to be approved in over a decade, joining Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil) in the drug class known as phosphodiesterase type 5 inhibitors, or PDE5 inhibitors. Roughly 30 million men in the United States are affected by erectile dysfunction, and according to at least one estimate, over 50% of men will develop ED within 10 years of developing diabetes.

The body produces a chemical called cGMP during sexual stimulation, which causes the blood vessels in the penis to dilate, resulting in an erection. cGMP is broken down by an enzyme known as phosphodiesterase-5 (PDE5). PDE5 inhibitors work by blocking the action of this enzyme, causing levels of cGMP to increase and leading to a better erection.


The safety and effectiveness of Stendra was established through three double-blind, placebo-controlled trials that involved a total of 1,267 people assigned to take Stendra for as long as 12 weeks. The medicine — which may be an option for men who do not respond to Viagra, Cialis, or Levitra — will be available in 50-milligram, 100-milligram, and 200-milligram doses and should be taken 30 minutes before sexual activity at the lowest dose necessary to be effective. According to the drug maker, Stendra may work faster for some men than other medicines in its class, potentially becoming effective in as little as 15 minutes. The medicine should not be taken more than once per day.

“This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs,” noted Victoria Kusiak, MD, of the FDA’s Center for Drug Evaluation and Research.

Stendra, along with all other medicines in the PDE5 inhibitor class, should not be taken by men who are taking nitrates, as the combination could cause a sudden drop in blood pressure. The most common side effects of Stendra include redness of the face and other areas, headache, nasal congestion, cold-like symptoms, and back pain. In rare cases, taking this drug can lead to an erection that lasts four or more hours. If this occurs, seek medical attention immediately. The drug can also rarely cause decreases in vision or hearing. Anyone experiencing this should stop taking PDE5 inhibitors and call a doctor immediately.

For more information about Stendra, see the article “FDA Approves New Impotence Drug Stendra,” read the press release on the Vivus Web site, or see Stendra’s official Web site.

  • Paul Washington

    The problem I have with these medications and the ineffectiveness of some is the price. I am on a fixed income and theses pills cost too much. Is the price of this new medication less? Pills now cost about $10.00 per pill.


    can i get a sample

  • Troy L. Sanders

    My concern is the same as Paul Washington in regards to cost and being on a “fixed income.” Can we get a sample before trying to find a way to pay for the pills?

    Thanks for your help and concern.

  • Marvin Bowen

    How can I get samples, none of the other pills work for me, and what about the price, will they be covered by the major medical insurances.

  • w. chane

    ED meds seem to work well..too well. not easy to reach orgasm without exhausting both partners. Does new drug offer help with this problem? No health issues..other than age.


    Is it possible to recieve a sample please,

  • George White

    Would like to try a sample. Also, is a daily pill available as is for Cialis? How does cost compare to the other three already on the market?

  • Diane Fennell

    Hi everyone,

    Thank you for your questions. The price of Stendra has unfortunately not yet been released. As far as obtaining samples goes, the best bet would probably be to try contacting the manufacturer directly at (866) 330-1871 or speaking to your health-care provider once the drug has been released (which is currently expected to happen sometime in the last quarter of 2012 or the first half of 2013).

    Diane Fennell
    Web Editor

  • Gary Enochs

    I have been on all the above also and with no success. I’m 59 years old and it’s very frustrating not to be able to get an erection when the time comes. I also would like to have some samples to try.

    And will it be covered under our insurance?


  • Laura

    Maybe now my husband will be able to help me participate in “The Sex Diet.” Lol! ( )

    I wish! Well whenever this drug comes out I’ll be the first to order it and that book, I could use a healthy dose of sex.

    Girl’s gotta dream :-)


  • Lamar

    How can I get a free sample. How much will it cost me?



  • Romy Estrada

    I’m not a diabetic. How can I get a free samples of STENDRA?

  • bill

    will insurance cover this ? How many tablets come in a box? Does the pill work if you have diabeties or have high blood pressure , if so how effective is it.

  • victor

    It is the month of september, 2013. Has this pill been released yet and how good doest it work for diabetics? Thank you.

  • bill

    How well does stendra works with you having high blood pressure or being a diabetic ? What drug store sales it and is it covered under insurance ?

  • trevor

    live in south africa durban wer can i gt it

  • Mark R.

    Hi! I hope there’s a trial pack for this. Since it’s still new in the market maybe there should be enough product information about this new drug. Thanks!

  • Bill

    how well does the pill work on people that have high blood pressure or is a diabetic ?

  • Marvin Wayne Brunson

    I would like to know where I can get it and the cost and would like to know if it really works I have type 2 diabetic and high blood which are under control please let me know thanks.