FDA approves VYBRIQUE (sildenafil oral film) first dissolvable film for ED in men. Learn efficacy, dosing, safety, and March 2026 launch details.
Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration (FDA) has approved VYBRIQUE (sildenafil oral film), an innovative dissolvable film formulation of sildenafil developed by IBSA USA. This marks the first FDA-authorized oral film for treating erectile dysfunction (ED) in adult men, offering a discreet new delivery option for this established therapy.
Nicholas Hart, CEO of IBSA USA, noted that despite rising awareness, ED remains a sensitive issue for many men who prioritize discretion. “VYBRIQUE addresses evolving patient needs with this convenient format,” he said.
What Is VYBRIQUE and How It Works
VYBRIQUE contains sildenafil, a phosphodiesterase type 5 (PDE-5) inhibitor that enhances blood flow to the penis during sexual stimulation, enabling erections sufficient for intercourse. Introduced in the late 1990s, sildenafil remains a cornerstone ED treatment.
Unlike tablets, VYBRIQUE is a thin film placed on the tongue that dissolves without water or chewing. Take it 30 minutes to 4 hours before sexual activity, with or without food. Available in four strengths (25 mg, 50 mg, 75 mg, 100 mg), it allows dosing flexibility.
Clinical Evidence and Efficacy
FDA approval stems from a randomized, double-blind, placebo-controlled trial (NCT05490680) with 475 men with ED. Over 12 weeks, VYBRIQUE doses showed statistically significant improvements in sexual function versus placebo, with clear dose-response effects. Under fasting conditions, peak plasma levels occurred in 30–300 minutes (median 80 minutes).
Safety and Important Considerations
Like other sildenafil products, VYBRIQUE’s vasodilatory effects may cause headache, flushing, upset stomach, nasal congestion, or dizziness. Rare serious risks include sudden vision/hearing loss or prolonged erections (priapism). It’s contraindicated with nitrates or certain other drugs providers must review concomitant medications.
Dr. Ralph Zagha, MD, Principal Investigator at Precision Clinical Research, added: “ED stems from age, anxiety, depression, and stress. A discreet, easy option like VYBRIQUE supports patient comfort and sexual health.”
Availability and Access
IBSA USA plans U.S. launch in March 2026 via direct-to-home delivery nationwide. This enhances convenience for the 30–50 million U.S. men affected by ED across ages.
For complete safety information, including patient and physician instructions, refer to the full prescribing information for VYBRIQUE in the U.S. Prescribing Information (USPI) and Patient Package Insert (PPI) at the links provided by IBSA USA.
References
VYBRIQUE Prescribing Information
A New Sildenafil Oral Film in Patients With Erectile Dysfunction, NCT05490680