PARSIPPANY, N.J. — IBSA USA said the U.S. Food and Drug Administration has approved VYBRIQUE, the first sildenafil oral film for the treatment of erectile dysfunction in men aged 18 years and older, introducing a new dosage form designed for discreet and convenient use.
Erectile dysfunction affects an estimated 30 to 50 million men in the United States and becomes more common with age, though cases among men under 40 are increasing. The company said the approval reflects growing demand for treatment options that align with patient preferences for flexibility, discretion, and ease of use.
VYBRIQUE is a single-dose oral film that dissolves on the tongue without the need for water or food. The therapy can be taken with or without meals and is intended for use approximately 30 minutes to four hours before sexual activity. It has been approved in four dosage strengths—25 mg, 50 mg, 75 mg, and 100 mg—allowing for individualized dosing based on patient needs.
“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.”
The FDA approval was supported by results from a randomized, double-blind, placebo-controlled, flexible-dose study involving 475 adult men with erectile dysfunction. Participants received VYBRIQUE at doses ranging from 25 mg to 100 mg over a 12-week period. According to the company, the study’s co-primary efficacy endpoints assessed at Week 4 showed statistically significant improvements in sexual function compared with placebo. Pharmacokinetic analyses indicated that peak plasma concentrations were achieved between 30 and 300 minutes under fasting conditions, with a median time of 80 minutes.
“Beyond age-related factors, research shows that anxiety, depression, and stress can contribute to ED,” said Dr. Ralph Zagha, MD, principal investigator at 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.”
IBSA USA said direct-to-home delivery of VYBRIQUE will be available in all states, with U.S. commercial availability anticipated in March 2026.
