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. 


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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.

References

  1. 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. 
  2. Zilxi [package insert]. Bridgewater, NJ: Vyne Therapeutics; 2020.

This article originally appeared on MPR