FDA has approved Vybrique, the first oral film formulation of sildenafil for the treatment of erectile dysfunction, offering a new delivery option for one of the most widely prescribed therapies in men’s sexual health.

The approval grants IBSA USA (the US subsidiary of Swiss pharmaceutical company IBSA) the ability to market Vybrique for men aged 18 years and older with erectile dysfunction. Unlike traditional tablets, the single-dose film dissolves on the tongue without water and can be taken between 30 minutes and four hours before sexual activity, with or without food.¹

Erectile dysfunction affects an estimated 30-to-50 million men in the United States and becomes more common with age.² However, rates among younger men have been rising, reflecting a broader mix of contributing factors that extend beyond aging alone. Clinicians increasingly point to lifestyle, cardiovascular health, and mental health conditions such as anxiety, depression, and chronic stress as contributors to sexual dysfunction, particularly in younger populations.²

“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.”

What was Vybrique’s approval based on?

The approval of Vybrique reflects a broader trend toward alternative drug delivery formats designed to reduce barriers to use, particularly for conditions that carry social stigma.¹ Oral films and dissolvable formulations continue to gain traction in other therapeutic areas by offering portability and ease of administration, attributes that can influence adherence in real-world settings.

From a regulatory and clinical standpoint, the approval does not introduce a new active pharmaceutical ingredient, but rather a new formulation of sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor that has been a mainstay of ED treatment for more than two decades.¹

As a result, the clinical and commercial significance of Vybrique relies less on therapeutic novelty and more on convenience, adherence, and patient preference, areas that have become increasingly important as competition in the ED market intensifies.¹

Vybrique was evaluated in a randomized, double-blind, placebo-controlled, flexible-dose study involving 475 adult men with erectile dysfunction.¹ Participants received doses ranging from 25 mg to 100 mg spanning over a 12-week period. The study met its co-primary efficacy endpoints at Week 4, demonstrating statistically significant improvements in sexual function compared with placebo.¹ Pharmacokinetic analyses showed 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 is positioning Vybrique to address a treatment gap for men seeking discreet and flexible dosing options. The company has not yet disclosed pricing or launch timelines.

Sources

1. IBSA USA Announces FDA Approval of Vybrique, the First and Only Oral Film to Treat Men with Erectile Dysfunction IBSA USA February 5, 2026 https://www.businesswire.com/news/home/20260205186522/en/IBSA-USA-Announces-FDA-Approval-of-VYBRIQUE-the-First-and-Only-Oral-Film-to-Treat-Men-with-Erectile-Dysfunction
2. Symptoms & Causes of Erectile Dysfunction. National Institute of Diabetes and Digestive and Kidney Disease Accessed February 5, 2026. https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/symptoms-causes