On December 16, 2025, the FDA approved VYBRIQUE, a sildenafil oral film from IBSA, for the treatment of erectile dysfunction (ED).1 It is a meaningful new option in how one of the world’s most widely used ED medications can be delivered.
As a board-certified urologist who treats men with erectile dysfunction every day, I want to explain what VYBRIQUE is, how it works, and what it may mean for patients at our practice.
What is VYBRIQUE?
VYBRIQUE is a single-dose oral film that contains sildenafil — the same active ingredient found in Viagra and its generic equivalents. The film is placed on the tongue, where it disintegrates and can be swallowed with saliva, without water or other liquids.2 That makes it a more discreet and convenient alternative to a pill for some men.
The approval was based on a 12-week, randomized, double-blind, placebo-controlled trial involving 475 adult men with ED (354 received VYBRIQUE and 121 received placebo), including men with diabetes, high blood pressure, high cholesterol and obesity. The study showed statistically significant improvements in sexual function compared with placebo. The FDA also relied in part on the efficacy data from the trials of sildenafil tablets.2
Why this matters for ED patients
Sildenafil has been a cornerstone of oral ED treatment since the FDA approved Viagra in 1998.3 The medication is well studied and widely prescribed. However, some men find pills inconvenient, particularly in spontaneous situations. An oral film addresses several practical concerns:
- No water needed — the film dissolves on the tongue
- Discreet — no pill bottle to carry
- Familiar active ingredient — same sildenafil, same mechanism, different delivery
- A 75 mg strength, between the 50 mg and 100 mg doses that the tablets offer23
The label makes no claim that the film works faster than a tablet. Peak blood levels are reached a median of 80 minutes after a dose on an empty stomach, and a high-fat meal slows absorption further.2
VYBRIQUE vs Viagra
Both products contain sildenafil and share the same dosing rules. The practical difference is the form.
| Detail | VYBRIQUE | Viagra |
|---|---|---|
| Active ingredient | Sildenafil | Sildenafil |
| Form | Oral film, dissolves on the tongue; no water needed | Film-coated tablet |
| Strengths | 25, 50, 75 and 100 mg | 25, 50 and 100 mg |
| Usual dose | 50 mg about 1 hour before sex | 50 mg about 1 hour before sex |
| Timing window | 30 minutes to 4 hours before sex | 30 minutes to 4 hours before sex |
| How often | No more than once a day | No more than once a day |
| Nitrates | Must not be combined | Must not be combined |
If sildenafil tablets already work well for you and swallowing them is not a problem, the film is a matter of convenience rather than a stronger treatment. If tablets have not worked, switching to the film is unlikely to change that, because the medicine is the same.
Where does VYBRIQUE fit in ED treatment?
Erectile dysfunction treatment is not one-size-fits-all. At Urological Consultants of Florida, Dr. Robbins works with each patient to identify the most appropriate approach based on his medical history, the underlying cause of his ED, and his goals. The available options include:
- Oral medications (sildenafil, tadalafil, vardenafil, avanafil, and now VYBRIQUE)
- Low-intensity shockwave therapy
- Penile injection therapy
- Vacuum erection devices
- Penile implant surgery for men who have not responded to other treatments
VYBRIQUE does not change the pharmacology of sildenafil — it changes the delivery format. Men who have responded well to sildenafil in pill form may find the dissolving film more convenient. Men who have not responded to oral medications will still need to explore other treatment approaches.
Important considerations
Like all sildenafil products, VYBRIQUE must not be taken with nitrates, such as those prescribed for chest pain, because together they can lower blood pressure dangerously. The label also rules it out with riociguat and similar medicines, and for anyone allergic to sildenafil.2 Men with heart conditions should talk to their doctor before starting any ED medication. VYBRIQUE is a prescription medication and is not available over the counter.
Talk to Dr. Robbins about your ED treatment options
If you are experiencing erectile dysfunction, the most important step is a thorough evaluation by a board-certified urologist who can identify the underlying cause and recommend a treatment. To learn more, visit our erectile dysfunction page or our overview of treatment options for ED, or call (305) 672-4222 to schedule an appointment.
Sources
- U.S. Food and Drug Administration. NDA 210858 approval letter, Vybrique (sildenafil) oral film.
- U.S. Food and Drug Administration. VYBRIQUE (sildenafil) oral film: prescribing information.
- U.S. Food and Drug Administration. VIAGRA (sildenafil citrate) tablets: prescribing information.
