Viagra, Cialis, and Levitra may have some competition next year. The Food and Drug Administration (FDA) has agreed to review the new drug application for avanafil, an investigation drug candidate for treatment of erectile dysfunction. Completion of the FDA’s review of this potential new addition to the erectile dysfunction arsenal is expected to be April 29, 2012.
Avanafil is a PDE5 (phosphodiesterase type 5) inhibitor, as are the other three erectile dysfunction drugs on the market. This new drug works by preventing or blocking a protein in the blood so the blood vessels can expand and allow blood to enter the penis, resulting in an erection during sexual arousal.
Vivus, Inc., makers of avanafil, previously announced the results of its phase 3 trials. Results of one trial presented in May at the 2011 Annual Meeting of the American Urological Association in Washington, DC, noted that use of the drug allowed 80% of men in the trial to get erections significant enough for intercourse and that intercourse was successful as quickly as 15 minutes. The most common side effects associated with avanafil were reported to be headache (5.6%), skin flushing (3.5%), inflammation of the nasal passages (3.4%), and nasal congestion (2.1%).
Overall, avanafil was tested in more than 1,350 patients, and the drug was found to be well tolerated and effective in treating men with general erectile dysfunction as well as men with diabetes and ED.
Read more in our Erectile Dysfunction Health Center.