Erectile dysfunction (ED) affects millions of men and can be stressful to manage. A new option just cleared by the U.S. Food and Drug Administration (FDA) may make treatment easier and more discreet: Vybrique™, the first FDA‑approved sildenafil oral film that dissolves on the tongue.
What is Vybrique and why does it matter?
Vybrique is an oral film formulation of sildenafil, the same active ingredient found in traditional ED tablets like Viagra. Instead of swallowing a pill, you place a thin film on your tongue where it dissolves without water. That makes it more discreet and convenient for people who prefer not to carry or swallow pills. The FDA approved Vybrique for adult men with ED February 5, 2026.
This approval is notable because it’s the first sildenafil oral film approved in the U.S., offering a new dosage form that may better match some patients’ preferences for convenience and discretion. The company behind Vybrique, IBSA USA, says the product will be available through direct‑to‑home delivery and in pharmacies starting March 2026.
How Vybrique works
Sildenafil belongs to a class of drugs called PDE5 inhibitors. During sexual arousal, these drugs help relax blood vessels in the penis so more blood can flow in, which helps produce and maintain an erection. Vybrique delivers sildenafil through a dissolving film on the tongue, which then gets absorbed into the bloodstream. Peak blood levels were seen between about 30 and 300 minutes after taking the film, with a median of roughly 80 minutes in the clinical study.
What the clinical trial found
The FDA decision was supported by a randomized, double‑blind, placebo‑controlled phase 3 study that enrolled 475 men with ED. Participants used Vybrique at flexible doses (25 mg, 50 mg, 75 mg, or 100 mg) or placebo over 12 weeks. The study measured improvements using standard questionnaires that ask about erection quality and whether intercourse was successful. Results showed statistically significant improvements in sexual function for men taking Vybrique compared with placebo.
Key trial highlights:
- Participants: 475 men randomized to Vybrique or placebo.
- Dosing: Younger men typically started at 50 mg; men 65 and older started at 25 mg; doses could be adjusted up to 100 mg (or 50 mg for older men) based on response and tolerability.
- Timing: The film can be taken 30 minutes to 4 hours before sexual activity, with a recommended starting dose of 50 mg for most adults.
These results suggest the oral film works similarly to tablet forms of sildenafil in improving erectile function, while offering a different way to take the medicine.
How to use Vybrique safely
Basic instructions:
- Place the film on your tongue and let it dissolve; do not cut or chew it.
- You can take it with or without food.
- Take it once per day at most, and plan for sexual activity about 1 hour after dosing (it can be taken 30 minutes to 4 hours before).
Important safety notes:
- Do not take Vybrique if you are using nitrates (medicines often used for chest pain), because the combination can cause a dangerous drop in blood pressure.
- Tell your healthcare provider about all medicines you take, especially those for high blood pressure, heart disease, or pulmonary hypertension.
- Serious but rare side effects reported with sildenafil products include prolonged erections (priapism), sudden vision loss, and sudden hearing loss. Seek immediate medical care if these occur.
Common side effects seen in the trial and with sildenafil generally include headache, flushing, upset stomach, nasal congestion, back pain, muscle aches, nausea, dizziness, and changes in vision. Most are temporary and mild to moderate.
Who might prefer the oral film?
A short comparison helps show where the oral film could fit in:
| Feature | Vybrique (oral film) | Traditional sildenafil tablet |
| How to take | Dissolve on tongue; no water needed | Swallow with water |
| Discretion | High; small sealed pouch, dissolves silently | Moderate; pill bottle or blister pack |
| Timing flexibility | 30 minutes to 4 hours before activity | Typically 30–60 minutes before activity |
| Available strengths | 25 mg, 50 mg, 75 mg, 100 mg | Similar strengths available |
| Common side effects | Headache, flushing, dizziness, vision changes | Headache, flushing, dyspepsia, vision changes |
This table is a quick snapshot; your doctor will help decide which form and dose are best for you.
Cost, availability, and privacy
IBSA USA has said Vybrique will be commercially available in March 2026, with a direct‑to‑home delivery option across all U.S. states. That could make it easier for people who prefer privacy or who have difficulty getting to a pharmacy. Pricing and insurance coverage will vary, so check with your insurer and local pharmacy.
If cost or access is a concern, ask your healthcare provider about generic sildenafil tablets, patient assistance programs, or pharmacy discount programs. Generic sildenafil tablets have been available for years and are often less expensive.
Questions to ask your healthcare provider
When you talk with a clinician about Vybrique or any ED treatment, consider asking:
- Which dose should I start with and how will we adjust it?
- Are there any medicines I take that would interact with sildenafil?
- What side effects should I watch for, and when should I seek emergency care?
- Is the oral film a good option for me compared with tablets or other ED treatments?
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Source
IBSA USA press release: IBSA USA Announces FDA Approval of VYBRIQUE™, the First and Only Oral Film to Treat Men with Erectile Dysfunction.