FDA Approves Sildenafil as First Oral Film to Treat Men With Erectile Dysfunction

IBSA USA recently announced the FDA approval of sildenafil (Vybrique), marking a significant milestone as the first oral film of its kind available for the treatment of erectile dysfunction (ED) in men 18 years and older, according to a news release.¹

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

This novel therapy utilizes proprietary FilmTec technology, which allows the medication to dissolve quickly on the tongue without the necessity of water or food. This delivery system offers a discreet administration option that can be taken anywhere from 30 minutes to 4 hours before patients’ sexual activity, with peak plasma concentrations typically reached in a median of 80 minutes.

The approval comes at a time when ED is increasingly recognized as a widespread condition affecting between 30 and 50 million men in the United States—with a notable rise in prevalence among those under the age of 40.

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Sources indicate that the condition is often multifactorial, involving vascular health, nerve function, and psychological factors such as anxiety, depression, and stress. Because the blood vessels involved in the drug’s mechanisms are relatively small, erectile issues can sometimes serve as an early predictor for heart attacks or strokes years before they occur.^1,2

“There’s a vascular component to erectile function that can be related to cardiac function, vascular health, [and] diabetes,” Amanda R. Swanton, MD, PhD, a urologist at University of Iowa Health Care, according to the American Medical Association, said.² “[There’s also a] nerve component to erectile dysfunction that can be impacted by diabetes or neurological disorders. Hormones also play a role.”

Serving as a new option for improving more than just sexual activity, but also potential cardiovascular risk, IBSA’s Vybrique will be available in 4 dosage strengths—25 mg, 50 mg, 75 mg, and 100 mg. These options enable a tailored therapy to support individual patient needs. As a phosphodiesterase type 5 (PDE5) inhibitor, sildenafil works by relaxing muscles to increase blood flow, though the medication requires sexual stimulation to facilitate an erection.^3,4

“VYBRIQUE was evaluated in a randomized, double-blind, placebo-controlled, flexible-dose study of 475 adult men with ED…[giving] participants VYBRIQUE at doses of 25 mg, 50 mg, 75 mg, and 100 mg,” wrote the authors of the news release.¹ “The study’s co-primary efficacy endpoints, assessed at Week 4, demonstrated that Vybrique provided superior improvements in sexual function compared with placebo.”

What Pharmacists Need to Know About Vybrique

Pharmacists should advise patients that while the film can be taken with or without food, it does not protect against sexually transmitted diseases like HIV. Safety counseling remains a primary responsibility in the dispensing process, as Vybrique is strictly contraindicated for patients using nitrates—like nitroglycerin or isosorbide—due to the risk of a sudden and dangerous drop in blood pressure. It is also contraindicated for those taking guanylate cyclase stimulators like riociguat.¹

Common adverse effects observed during clinical evaluations included headache, flushing, upset stomach, nasal congestion, and dizziness.

The expertise of the pharmacist is vital in identifying potential drug-drug interactions, as sildenafil can interact with alpha-blockers, HIV protease inhibitors, and certain oral antifungal or antibiotic medications. Beyond oral medications, patients who do not respond to PDE5 inhibitors may eventually require alternative interventions such as self-injection therapy with alprostadil, intraurethral suppositories, or vacuum erection devices.^1,3,4

Lifestyle modifications, including smoking cessation, maintaining a healthy weight, and increasing physical activity, are frequently recommended as proactive measures to improve ED and overall vascular health. It is also important for pharmacists to screen for underlying conditions such as diabetes or heart disease during the diagnostic process and consultations surrounding the use of medications like Vybrique.^3,4

As the drug prepares for a projected US commercial launch in March 2026, it represents a shifting landscape in men’s health that prioritizes patient discretion and approachable treatment options.¹

“Beyond age-related factors, research shows that anxiety, depression, and stress can contribute to ED,” concluded Ralph Zagha, MD, an expert in urology practice, according to the 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.”

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REFERENCES

1. IBSA USA announces FDA approval of VYBRIQUE, the first and only oral film to treat men with erectile dysfunction. IBSA USA. News Release. 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. Berg S. What doctors wish patients knew about erectile dysfunction. AMA. November 1, 2024. Accessed February 5, 2026. https://www.ama-assn.org/public-health/prevention-wellness/what-doctors-wish-patients-knew-about-erectile-dysfunction

3. Erectile dysfunction. Mayo Clinic. March 1, 2025. Accessed February 5, 2026. https://www.mayoclinic.org/diseases-conditions/erectile-dysfunction/diagnosis-treatment/drc-20355782

4. Treatment for erectile dysfunction. National Institute of Diabetes and Digestive and Kidney Diseases. October 2024. Accessed February 5, 2026. https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/treatment