Vyne Therapeutics announced the availability of Zilxi (minocycline) topical foam 1.5% for the treatment of inflammatory lesions of rosacea in adults.
Zilxi utilizes the Company’s proprietary Molecule Stabilizing Technology (MST™) platform to deliver minocycline, a tetracycline-class drug, in a foam formulation. It is the first FDA-approved minocycline product of any form for rosacea.
Each gram of Zilxi contains 15mg of minocycline equivalent to 16mg of minocycline hydrochloride and is supplied as a yellow suspension in 30-gram aerosol containers. The propellant in the product is flammable; patients should be instructed to avoid fire, flame, and smoking during and immediately following application. The annual list price of Zilxi will be $485 per 30-gram canister.
In May 2020, the FDA approved Zilxi based on efficacy and safety data from two phase 3 trials (Trial 1 and Trial 2), which included 1522 patients aged 18 years and older with moderate to severe facial papulopustular rosacea. Findings from both studies showed that Zilxi met the co-primary end points achieving statistically significant improvements in inflammatory lesion counts and the Investigator Global Assessment treatment success at week 12 compared with vehicle.
As for safety, Zilxi was well tolerated with the most commonly reported adverse reaction (≥1%) being diarrhea.
“Patients and physicians have been seeking new treatment options for rosacea, a condition that can be difficult to treat, leaving many patients dissatisfied and, in some cases, switching treatments multiple times or discontinuing altogether,” said David Domzalski, CEO of Vyne. “By combining a unique topical delivery system for minocycline with strong efficacy and tolerability, Zilxi is positioned to address a very challenging skin condition in a way that could change treatment considerations for rosacea.”
For more information visit zilxi.com.
- Vyne Therapeutics announces Zilxi™ (minocycline) topical foam, 1.5% available in pharmacies nationwide on October 1st. https://www.prnewswire.com/news-releases/vyne-therapeutics-announces-zilxi-minocycline-topical-foam-1-5-available-in-pharmacies-nationwide-on-october-1st-301143663.html. Accessed October 1, 2020.
- Zilxi [package insert]. Bridgewater, NJ: Vyne Therapeutics; 2020.