FDA approves first topical minocycline for rosacea

May 29, 2020

The U.S. Food and Drug Administration has approved FMX103 (ZILXI, Menlo Therapeutics), a topical 1.5% minocycline foam for the treatment of inflammatory lesions of rosacea in adult patients.

Another topical rosacea treatment enters the market with the United States Food and Drug Administration (FDA) approval of FMX103 (ZILXI, Menlo Therapeutics), a 1.5% minocycline foam, equipped with the company’s proprietary Molecule Stabilizing Technology (MST), for the treatment of inflammatory lesions of rosacea in adult patients.1

Oral minocycline has been on the market for numerous years for acne vulgaris but is now being developed into a topical formulation to treat both acne and rosacea. Previously, a 4% topical minocycline foam (Amzeeq) developed by Menlo’s now wholly-owned subsidiary Foamix Pharmaceuticals Ltd. was approved by the FDA for treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in pediatric patients and adults on Oct. 18, 2019.2

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With this recent approval, FMX103 is now the first approved minocycline product to treat rosacea, according to a company press release.1

“This is the only product containing minocycline approved by the FDA for rosacea,” says Iain Stuart, Ph.D., chief scientific officer of Menlo. “The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions.”

The approval follows results from two randomized, multicenter, vehicle-controlled, double-blind clinical trials that enrolled 1,522 patients 18 years and older. During the trials, patients with rosacea-related papules and pustules were given either FMX103 or vehicle daily for 12 weeks. 

FMX103 met all co-primary endpoints in both trials, which included an absolute mean change inflammatory lesions counts from baseline at week 12 and a proportion of patients who achieved an Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) with a minimum of a two-grade decrease from baseline at week 12. FMX103 also demonstrated superiority over vehicle and statically significant decrease in inflammatory lesion count and IGA success.1

Additionally, erythema was investigated during the trials, with 40.9% and 48.3% of FMX103 patients being clear or almost clear of erythema at week 12.3

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Tolerability of the drug was assessed with 95% of FMX103 subjects having skin tolerability scores of mild or none at application site at week 12. While no serious treatment-related adverse events were reported, the most prevalent adverse reactions during the trials included diarrhea, which was reported by ≥1% of FMX103 patients compared to vehicle, respectively.3

“This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder,” says David Domzalski, CEO of Menlo. “ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective.”

The company says they expect to have FMX103 available on the market by the 4th quarter of 2020.

References:

1. Menlo Therapeutics Receives FDA Approval of ZILXI™ (minocycline) topical foam, 1.5%, the First Topical Minocycline Treatment for Rosacea. (2020, May 29). Retrieved May 29, 2020, from http://ir.menlotherapeutics.com/news-releases/news-release-details/menlo-therapeutics-receives-fda-approval-zilxitm-minocycline
2. Boxler, D. (2019, October 21). Minocycline Topical Foam 4% Approved by FDA for Acne Vulgaris. Retrieved May 29, 2020, from https://www.dermatologytimes.com/acne/minocycline-topical-foam-4-approved-fda-acne-vulgaris
3. Foamix Announces Publication of Phase 3 Studies Evaluating FMX103 for the Treatment of Papulopustular Rosacea in Journal of the American Academy of Dermatology. Foamix Pharmaceuticals Ltd. https://www.foamix.com/news-releases/news-release-details/foamix-announc.... Published February 6, 2020. Accessed May 29, 2020.