What was approved
On 5 February 2026 the FDA approved Vybrique, a sildenafil oral film made by IBSA, for erectile dysfunction in men over 18. It reached the US market the following month. It comes in four strengths — 25, 50, 75 and 100 mg — and dissolves on the tongue without water, with or without food.
The active ingredient is sildenafil. Not a relative of it, not a new molecule: the same drug that has been sold as Viagra since 1998 and as a cheap generic for over a decade. What is new is the delivery format and the fact that this particular format now has an approval behind it.
Why an approval for a format matters
A large part of the online ED market sells compounded troches and rapid-dissolve tablets — sublingual and buccal products, mixed to order by compounding pharmacies, pitched on being faster and more discreet than swallowing a tablet.
None of them are FDA approved. Compounded medicines are not reviewed for safety, effectiveness or quality, and most of the pages selling them do not publish a dose. Of the reviews on this site, a substantial share are exactly this: a dissolvable something, at an unstated strength, from a pharmacy you cannot look up.
So the useful thing about this approval is not that a film is exciting. It is that the format now exists in a version with a trial, a label, published strengths and a manufacturer with an address. If the reason you were considering a troche was that swallowing tablets is genuinely difficult, that reason is now served by an approved product. What the compounded market actually looks like.
What the trial showed
A phase 3 randomised, double-blind, placebo-controlled trial in 475 men over 12 weeks. Men under 65 started at 50 mg; men 65 and over started at 25 mg, with the dose adjustable in either direction. The study met its co-primary endpoints, showing improvement in sexual function against placebo.
For an approved drug this is unremarkable, which is the point. It is a normal evidence package of exactly the kind that no compounded troche has.
The speed claim, checked against the numbers
Much of the coverage of this approval repeated that the film works faster than a sildenafil tablet. It is worth looking at the manufacturer's own pharmacokinetic data before believing it.
| Vybrique film | Sildenafil tablet | |
|---|---|---|
| Time to peak level (median) | 80 minutes | about 60 minutes |
| Range | 30–300 minutes | about 30–120 minutes |
| Labelled dosing window | 30 minutes to 4 hours before sex | 30 minutes to 4 hours before sex |
On the published figures the film peaks slightly later than a tablet, with a wider spread, and carries the same labelled dosing window Viagra has had for twenty-five years. Whatever the film's advantages are, arriving sooner does not appear to be one of them.
This is not an accusation of dishonesty. Dissolving in the mouth feels faster than swallowing something, and clinicians quoted at approval were describing convenience more than kinetics. But if you are choosing between formats, choose on the thing that is actually different.
What is actually different
- No water needed, and nothing to swallow. If you have difficulty swallowing tablets — after a stroke, with a dry mouth from other medication, or simply as a long-standing problem — this is a real benefit and not a small one.
- Discretion. A film in a wallet is less conspicuous than a blister pack.
- Four strengths, including 75 mg, which is not a strength standard tablets come in.
- An FDA label, which is the difference between this and every compounded troche on the market.
What it costs
$8 a film through the manufacturer's direct programme, dispensed through a single specialty pharmacy. Cash prices quoted through ordinary retail channels were considerably higher.
Generic sildenafil tablets cost around $2 a pill from telehealth services and less from discount pharmacies — the same drug, at the same strengths, with the same label warnings. You are paying roughly four times as much for the format.
Whether that is worth it depends entirely on whether the format solves a problem you actually have. If swallowing tablets is difficult, $6 extra is trivially worth it. If it is not, you are buying convenience at a 300% premium. What ED medication should cost.
The safety information is the same, because the drug is the same
To the manufacturer's credit, all of this is on their website in full rather than summarised into marketing language — which, having audited three dozen ED product pages, is not something we say often.
Should you ask for it
If you have been considering a compounded troche: yes, ask about this instead. Same idea, real label, published dose, and you will know what you are taking.
If you struggle to swallow tablets: yes. This is the problem it solves.
If neither applies: probably not. A $2 generic sildenafil tablet is the same medicine, and the money is better spent on the appointment where somebody checks your blood pressure. Read the full review.