FDA

Vybrique oral film OK’d for erectile dysfunction

February 9, 2026

Brand name: Vybrique

Generic name: sildenafil oral film

Manufacturer: IBSA

Approval date: February 5, 2026

FDA has approved Vybrique (sildenafil) oral film for the treatment of erectile dysfunction (ED).

According to a manufacturer press release, Vybrique is supplied as a single‑dose, orally dissolving film designed to be taken without water, offering a portable option for patients. It may be administered 30 minutes to 4 hours before anticipated sexual activity and can be used with or without food.

Efficacy

Approval was based on data from a randomized, double‑blind, placebo‑controlled trial (NCT05490680) involving 475 adult men with erectile dysfunction, in which Vybrique was tested using a flexible‑dose regimen (25–100 mg) over 12 weeks. At the week 4 assessment, the study met its co‑primary endpoints, with Vybrique demonstrating significantly greater improvements in sexual function compared with placebo. Pharmacokinetic data indicated that, in fasting participants, peak plasma levels occurred between 30 and 300 minutes, with a median time of 80 minutes.

Safety

The most common adverse reactions (≥2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash.

Sources:

Vybrique (sildenafil oral film) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210858s000lbl.pdf Revised December 2025. Accessed February 6, 2026.

IBSA USA announces FDA approval of Vybrique™, the first and only oral film to treat men with erectile dysfunction. [News release]. IBSA. 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