First Oral Film Treatment for Erectile Dysfunction in Men Gains FDA Approval

The US Food and Drug Administration (FDA) has approved the first sildenafil oral film (VYBRIQUE™, IBSA) for men aged 18 years and older with erectile dysfunction (ED), IBSA USA announced in a news release.¹ The product, VYBRIQUE™, represents a new formulation option for phosphodiesterase type 5 inhibitor therapy.¹

According to the company, VYBRIQUE is a single-dose oral film that dissolves on the tongue without the need for water or other liquids. The sildenafil oral film may be taken with or without food and is intended for use 30 minutes to 4 hours before sexual activity.¹

“Beyond age-related factors, research shows that anxiety, depression, and stress can contribute to ED,” Ralph M. Zagha, MD, of Precision Clinical Research, said in the news release. “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.”¹

The FDA approval was supported by results from a phase 3 randomized, double-blind, placebo-controlled, flexible-dose trial (NCT05490680) that enrolled 475 adult men with erectile dysfunction at clinical sites across the US. The 12-week study evaluated the efficacy and safety of sildenafil oral film at doses of 25 mg, 50 mg, 75 mg, and 100 mg.^1,2

Participants were randomly assigned to receive sildenafil oral film or placebo. Patients younger than 65 years of age received a starting dose of 50 mg, while those aged 65 years and older received a starting dose of 25 mg. Dose adjustments were permitted during the trial based on individual response and tolerability.^1,2

The study met its coprimary efficacy endpoints, demonstrating superior improvements in sexual function with sildenafil oral film compared with placebo. Pharmacokinetic analyses showed that peak plasma concentrations were reached between 30 and 300 minutes under fasting conditions, with a median time to peak concentration of 80 minutes.^1,2

“While awareness and open discussion around ED have grown, it’s still a sensitive topic where many men value discretion,” Nicholas Hart, CEO of IBSA USA, said in the release. “The FDA approval of VYBRIQUE provides men experiencing ED with a novel treatment option that helps meet the evolving needs of patients today.”¹

According to IBSA, sildenafil oral film is expected to be commercially available in the US in March 2026. The company also reported that direct home delivery will be available nationwide, offering an additional fulfillment option for patients.¹

References:

1. IBSA USA announces FDA approval of VYBRIQUE™, the first and only oral film to treat men with erectile dysfunction. News release. IBSA USA. February 5, 2026. Accessed 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. A new sildenafil oral film in patients with erectile dysfunction. ClinicalTrials.gov. Last updated October 23, 2025. Accessed February 5, 2026. https://clinicaltrials.gov/study/NCT05490680?term=IBSA&cond=Erectile%20Dysfunction&rank=1