Stendra Data Revealed at a Recent SMSNA Meeting
New tests indicate that Stendra can end the frustration and embarrassment of impotence within 15 minutes after the drug is taken.
Auxilium Pharmaceuticals, which markets Stendra in the United States and Canada, offered new insights into the workings of the impotence drug at the annual fall scientific meeting of the Sexual Medicine Society of North America. The drug company said it hoped that analyses of data from recent studies of the drug that it was releasing would provide a better understanding of Stendra’s clinical profile.
Stendra is the brand name for the most recent PDE5 inhibitor to come to the U.S. market. Its active ingredient is avanafil. Stendra was originally given the green light by the U.S. Food and Drug Administration in April 2012. At that time, the FDA authorized U.S. marketing of the drug for use 30 minutes or more before sexual activity.
Developed by VIVUS
Stendra’s original developer is VIVUS Inc., which is headquartered in Mountain View, California. Auxilium licenses exclusive U.S. and Canadian marketing rights to Stendra from VIVUS. Avanafil for erection problems is marketed as Spedra in the countries of the European Union.
Auxilium also was particularly anxious to share with conference attendees the clinical data behind the FDA’s September 2013 approval of Stendra for use as little as 15 minutes before sex.
At the November meeting in Miami, Laurence H. Belkoff, D.O., chairman of the Division of Urology at the Philadelphia College of Osteopathic Medicine, said that his patients with erection problems ¨are looking for a safe and effective treatment with a rapid onset of action and a favorable side effect profile.¨
Belkoff’s Links to Auxilium
Dr. Belkoff, who is also chairman of the Philadelphia school’s Department of Specialty Surgeries, has participated in clinical studies of Stendra and has also served as a speaker on Auxilium’s behalf in the past.
The latest test data on the drug, said Dr. Belkoff, ¨reinforce that Stendra is an appropriate treatment option with the ability to provide a meaningful benefit to men suffering from ED and a rapid onset of action in many men as early as approximately 15 minutes before sexual activity.”
Auxilium presented an analysis of data from a placebo-controlled study in which test subjects made at least one attempt at intercourse within 15 minutes of taking the drug. Test subjects were randomly divided into three groups, one of which got a 100-milligram dose of Stendra, a second that got a 200-milligram Stendra tablet, and a control group that received a placebo.
In a post-study analysis of the data produced from that trial, researchers found that 73.3 percent of the men given a 100-milligram dose of Stendra were able to have successful intercourse within 15 minutes of taking the drug. Among those who took a 200-milligram dose of Stendra, the successful intercourse rate within 15 minutes was 71.5 percent.
Another Study Detailed
Another phase of the more recent studies of Stendra looked at the proportion of men with erection problems who were able to have successful intercourse within the first three doses of Stendra, compared with those who completed intercourse after taking a placebo. More than 60 percent of test subjects reported successful intercourse within the first three doses of Stendra, compared with about 40 percent on placebo.
Auxilium also released data showing that ¨a higher percentage (75 percent for Stendra versus 56 percent for placebo) also reported success after any dose.¨
When first approved for sale in the United States, Stendra became the fifth brand-name PDE5 inhibitor to become available to American men with erection problems. Approved drugs (and their active ingredients) among the PDE5 inhibitors available in the United States include Viagra (sildenafil citrate), Levitra (vardenafil), Cialis (tadalafil), Staxyn (an orally soluble formulation of vardenafil), and Stendra (avanafil).
Drugs Work in Same Way
Although each of the PDE5 inhibitors differs somewhat in chemical structure, all of them work in essentially the same way. This family of drugs gets its name for the medications’ ability to temporarily disable the phosphodiesterase-5 enzyme, which can impede strong blood flow to the penis.
Up until the last couple of decades, many medical professionals believed that erection problems were for the most part psychological in origin. In other words, men who were having trouble getting an erection were often told by their doctors that the problem was all in their heads.
It’s Blood Flow, Stupid
Today, most doctors recognize that the vast majority of erection problems are caused by compromised blood flow to the penis. Although the initial impetus for erection originates in the brain as feelings of sexual desire, that sets in motion a series of chemical reactions that culminate in a heavy flow of blood to the pelvic region. As this blood fills the spongy erectile tissue of the penis, an erection occurs.
Helping to facilitate the erectile process is a chemical substance known as cyclic guanosine monophosphate, or cGMP. This chemical relaxes the smooth muscles lining blood vessels that supply the penis. As they dilate, blood rushes in to fill erectile tissue.
Can Block cGMP’s Effects
One of the primary functions of the PDE5 enzyme is the breakdown of cGMP, but if an excess of PDE5 is present during the period preceding and during erection, it may short-circuit the process. This could either make it impossible to achieve an erection or end the erection before sexual activity can be completed.
Stendra, like the other PDE5 inhibitors, holds the PDE5 enzyme at bay for a limited period of time. In the case of Stendra, the drug’s effectiveness can last for more than six hours, compared with four to five for Viagra and Levitra and up to 36 hours for Cialis as Needed. This allows the erection function to proceed without impediment.
Despite their slight differences based on chemical structure, the PDE5 inhibitors share similar side effects, most of which are minor and often disappear as the drug is used more often. However, use of PDE5 inhibitors at the same time as nitrate-based medications can be extremely dangerous, even potentially life-threatening.
Don’t Mix with Nitrates
Nitrate-based drugs, such as nitroglycerin taken to ease the chest pains of angina, work by lowering blood pressure. PDE5 inhibitors have the same blood pressure-lowering effect. Thus, taking these drugs together can cause a dangerous drop in blood pressure.
Although serious side effects are rare, users of Stendra or other PDE5 inhibitors should be alert for any significant disturbances of vision and/or hearing and should consult their doctors if such symptoms persist. In rare cases, PDE5 inhibitors have been known to cause erections lasting four hours or more. Because these can cause permanent damage to erectile tissue, immediate medical care should be sought by anyone experiencing a protracted erection such as this.
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Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.