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Q: I heard that a new drug was approved for erectile dysfunction. What can you tell me about it?
A: In April 2012, the FDA approved Stendra (avanafil) to treat erectile dysfunction in men. It is the first new drug in a class of drugs call PDE5 inhibitors to be approved in a decade.
All PDE5 inhibitors work by increasing blood flow to the penis and sexual stimulation is required to initiate an erection. Other drugs in this class include Viagra (sildenafil), Cialis (tadalafil), and Levitra or Staxyn (varadenafil).
In clinical studies, Stendra was able to increase the rate of erections sufficient for sexual intercourse from less than 15 percent to as much as 57 percent compared to 27 percent with a “dummy pill” (placebo).
One potential advantage of Stendra is that it may work in as little as 15 minutes, but direct comparisons with other similar drugs are not available. The recommended starting dose for Stendra is a 100 mg tablet taken approximately 30 minutes before sexual activity.
Like other PDE5 inhibitors, Stendra should not be taken by men who take nitrates, commonly used to treat chest pain, because the combination can cause a sudden drop in blood pressure.
The most common side effects of Stendra reported in more than 2 percent of patients during clinical studies included headache, redness of the face and other areas, nasal congestion, common cold-like symptoms and back pain. In rare cases, some patients taking Stendra and other similar drugs may get an erection lasting longer than four hours, in which case they should seek immediate medical care.
ED occurs when a man has trouble getting or maintaining an erection, with an estimated 30 million American men affected by this problem. Its prevalence increases with age, and with various disease states such as diabetes, hypertension and/or vascular disease.
Richard P. Hoffmann, Pharm.D., has been a pharmacist for more than 40 years. Send questions to him at 2960 E. Coventry Court, Hernando, FL 34442.