IBSA USA, the U.S. subsidiary of the Swiss pharmaceutical company IBSA, announced that the FDA has approved VYBRIQUE™, the first sildenafil oral film available to treat men aged 18 years and older with erectile dysfunction.
Erectile dysfunction (ED) impacts an estimated 30 to 50 million men in the U.S. and becomes more prevalent with age. However, ED is not limited to older populations; cases among younger men are on the rise1. This trend highlights the importance of proactive measures, including healthy lifestyle choices and regular physical activity, to help reduce the risk of developing ED.
VYBRIQUE is a discreet, easy-to-use, single-dose film that dissolves on the tongue without the need for water or other liquids, providing an on-the-go use option that may be taken anywhere from 30 minutes to 4 hours before sexual activity. VYBRIQUE can be taken with or without food.
“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.”
VYBRIQUE was evaluated in a randomized, double-blind, placebo-controlled, flexible-dose study of 475 adult men with ED. Over the 12-week study, participants received VYBRIQUE at doses of 25 mg, 50 mg, 75 mg and 100 mg. The study’s co-primary efficacy endpoints, assessed at Week 4, demonstrated that VYBRIQUE provided superior improvements in sexual function compared to placebo. Additionally, pharmacokinetic analyses showed that peak plasma concentrations were reached between 30 and 300 minutes (median 80 minutes) under fasting conditions.
“Beyond age-related factors, research 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.”
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