FDA approves sildenafil oral film for men with erectile dysfunction

The FDA has approved the first sildenafil oral film, VYBRIQUE, for men aged 18 years and older with erectile dysfunction (ED), IBSA USA announced in a news release.¹

According to IBSA, VYBRIQUE is “a discreet, easy-to-use, single-dose film that dissolves on the tongue without the need for water or other liquids.” The oral film can be taken anywhere from 30 minutes to 4 hours before sexual activity and can be taken with or without food.

“Beyond age-related factors, research² shows that anxiety, depression, and stress can contribute to ED,” said Ralph M. Zagha, MD, Precision Clinical Research, in the news release.¹ “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.”

The approval of the oral film is backed by findings from a phase 3 randomized trial (NCT05490680), which demonstrated that VYBRIQUE provided superior improvements in sexual function vs placebo. In total, the 12-week study enrolled 475 adult men with ED across clinical trial sites in the US.³

Participants were randomly assigned to receive VYBRIQUE or placebo. Doses of VYBRIQUE were administered at 25 mg, 50 mg, 75 mg, and 100 mg. Patients younger than 65 years of age received a starting dose of 50 mg, and patients 65 years and older received a starting dose of 25 mg. The trial was conducted as a flexible-dose study, meaning that the starting dosage could be increased or decreased.

Overall, the study met its co-primary end points, with VYBRIQUE demonstrating superior improvements in sexual function vs placebo. Pharmacokinetic data also showed that peak plasma concentrations were reached between 30 and 300 minutes under fasting conditions. The median time to peak plasma concentrations was 80 minutes.

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

The sildenafil oral film is expected to be commercially available in the US in March 2026. IBSA also reported that direct home delivery of VYBRIQUE will be available in all states, “providing patients a convenient fulfillment option.”

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. 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

3. 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