FDA Approves VYBRIQUE, An Oral Film to Treat Erectile Dysfunction

The FDA has approved of the first sildenafil oral film available to treat men aged 18 years and older with erectile dysfunction (ED). This single-dose film dissolves on the tongue, and you don’t need to take it with food or water. You can take it between 30 minutes and four hours before sexual activity.

“While awareness and open discussion around ED have grown, it’s still a sensitive topic where many men value discretion,” said Nicholas Hart, IBSA USA CEO. “The FDA approval of VYBRIQUE provides men experiencing ED with a novel treatment option that helps meet the evolving needs of patients today.”

A Successful Clinical Trial

Researchers enrolled 475 men in a 12-week clinical trial to test doses of 25 mg, 50 mg, 75 mg, and 100 mg, and they concluded it was successful for men with ED.

“Beyond age-related factors, research2 shows that anxiety, depression, and stress can contribute to ED,” said Dr. Ralph Zagha, MD, Principal Investigator, Precision Clinical Research. “Providing a treatment option that is discreet and easy to administer supports men in managing ED in a way that feels approachable and respectful of their sexual health.”

ED is very common, affecting anywhere between 30 and 50 million men, but the good news is that it is very treatable, so that you can resume a regular sex life.

Precautions

Side effects include a slight drop in blood pressure, which can make you feel dizzy. This medication is not recommended for men with certain types of hypertension. It can cause priapism, which is an erection that won’t go away after four hours. Ask your healthcare provider before trying a new medication, and discuss potential risks or complications with other medications you may be taking.

Visit www.fda.gov/medwatch if you experience any negative side effects.