ZILXI™
(minocycline) topical foam, 1.5%

ZILXI

The first FDA-approved minocycline treatment for rosacea

ZILXITM (minocycline) topical foam, 1.5% is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults.

Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated.

Rosacea: An increasingly widespread skin disorder with potential burdens to patients1

Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules). It may create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that may adversely affect quality of life.2 Rosacea is most frequently seen in adults between 30 and 60 years of age.3 It affects more than 16 million1 people in the United States; up to 28% of these sufferers have rosacea with inflammatory lesions.

Treatments: Limited treatment options present opportunity for new product entry

ZILXITM (minocycline) topical foam, 1.5%:

ZILXITM is VYNE Therapeutics™’s proprietary 1.5% minocycline foam formulation indicated for the treatment of inflammatory lesions of rosacea in adults. ZILXITM is the first FDA-approved minocycline treatment for rosacea ever.

  • In two 12-week studies of 1,522 patients, Zilxi demonstrated an improvement vs. vehicle foam in both inflammatory lesions and IGA scores.5*
  • The most commonly reported adverse reaction was diarrhea (1%).5

Moisturizing and free of drying agents

  • The vehicle contains naturally moisturizingingredients4,5†:
    • Coconut oil
    • Soybean oil
    • Surfactant-free and does NOT contain drying agents, such as ethyl alcohol5

Indication

ZILXITM (minocycline) topical foam, 1.5% is a topical form of the antibiotic minocycline for the treatment of adults with pimples and bumps caused by a condition called rosacea. ZILXI is available by prescription only.

ZILXI should not be used for the treatment of infections. It is not known if ZILXI is safe and effective in children. ZILXI is for use on skin only (topical use). ZILXI is not for use in the mouth, eyes or vagina.

Important Safety Information

ZILXI should not be used in people who are allergic to ZILXI or any tetracycline medicine. Use of ZILXI should be stopped right away if a rash or other allergic symptom occurs.

ZILXI should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using ZILXI, she should talk to her doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.

ZILXI is flammable and fire, flames, and smoking must be avoided when applying and right after applying ZILXI.

People should protect their skin from the sun while using ZILXI and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of ZILXI should be stopped if skin is sunburned.

When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms.

ZILXI is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea, including watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes; bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or gums. People should call their doctor right away if these side effects occur.

The most common side effect of ZILXI is diarrhea.

These are not all of the possible side effects with ZILXI. People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using ZILXI.

People are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Patient Information.

† Zilxi 1.5% topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol, and propellants (butane + isobutane + propane)
*Coprimary endpoints at Week 12 were: Absolute change from baseline in inflammatory lesion count and Investigator’s Global Assessment (IGA) treatment success. IGA treatment success was defined as an IGA score of 0 or 1 (clear or almost clear), and at least a 2-grade improvement (decrease) from baseline at Week 12.

Subjects were required to have:

  • 15-75 facial lesions (papules and pustules) and no more than 2 facial nodules
  • IGA scale—moderate or severe score (grade 3 or 4)
  • History or presence of facial erythema and/or flushing

References:

  1. Two, et al. Rosacea. J Am Acad Dermatol. 2015 May;72(5):749-58
  2. Oussedik E, Bourcier M, Tan J. Dermatol Clin. 2018 Apr; 36(2):103-113. Epub 2017 Nov 29.
  3. Rosacea. National Institute of Arthritis and Musculoskeletal and Skin Diseases. https://www.niams.nih.gov/health-topics/rosacea#tab-risk.
  4. Lin TK, et al. Int J Mol Sci. 2017;19(1):70. doi: 10.3390/ijms19010070.
  5. ZILXI™ (minocycline) topical foam, 1.5% Prescribing Information. Bridgewater, NJ: Foamix Pharmaceuticals Inc; 2020.

Intended only for US residents.

ZILXI is a trademark of Foamix Pharmaceuticals Ltd. (a wholly owned subsidiary of VYNE Therapeutics Inc.)

© 2020 VYNE Therapeutics Inc. All Rights Reserved.

520 US Highway 22, Suite 204, Bridgewater, NJ, USA.
COM-FMX103-US-200012 09/2020