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ABOUT ZILXI

Minocycline Power With Molecule Stabilizing Technology (MST)™

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THE POWER OF MINOCYCLINEOUR PROPRIETARY VEHICLE

THE POWER OF MINOCYCLINE

ZILXI provides the established power of minocycline in a stable topical foam

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The Advantages of Minocycyline

ZILXI with the power of minocycline has proven to be effective in the fight against inflammatory lesions of rosacea

  • In 2 phase 3 trials, approximately 50.6% of patients receiving ZILXI achieved treatment success, which was defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a 2-grade improvement from baseline at week 121*
  • Shown to exhibit potent anti-inflammatory properties2*
  • A 1.5% concentration was found to be the clinically appropriate dose for treating inflammatory lesions of rosacea3†
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TRUST THE POWER OF ZILXI AS YOUR FIRST-LINE TREATMENT AGAINST INFLAMMATORY LESIONS OF ROSACEA IN ADULTS

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ZILXI OFFERS FIRST-LINE EFFICACY AGAINST ROSACEA IN THE ONLY TOPICAL MINOCYCLINE FOAM

*The mechanism of action of minocycline in treating inflammatory lesions in adults with rosacea is unknown.

†A phase 2 dose-finding study assessed the efficacy of topical minocycline foam 1.5% and topical minocycline foam 3% compared with vehicle. While both doses of topical minocycline were superior to vehicle in reducing inflammatory lesions and improving patient's Investigator’s Global Assessment (IGA) scores, no additional clinical benefit for topical minocycline foam 3% was observed compared with topical minocycline foam 1.5%.2

TRUST THE POWER OF ZILXI AS YOUR FIRST-LINE TREATMENT AGAINST INFLAMMATORY LESIONS OF ROSACEA IN ADULTS

OUR PROPRIETARY VEHICLE

ZILXI is enabled by a proprietary foam vehicle that leverages MST™

Picture of a bottle foam with an orange Zilxi label. A dollop of foam sits below the bottle

Developed with precision

  • Enables unstable molecules to be placed into a dermatologically purposeful vehicle for stable topical delivery5,6
  • Leverages micronized particles to increase coverage and penetration7,8
  • The foam formulation delivers minocycline to the topical site of action, with low systemic absorption99
  • The clinical significance of low systemic exposure with ZILXI is unknown

Formulated for ease of use

Emollient foams like ZILXI have a variety of functional advantages including:

  • Smooth application
  • Promotes molecule contact and penetration9

Moisturizing and free of drying agents

  • The vehicle contains naturally moisturizing ingredients10,11‡:
    • Coconut oil
    • Soybean oil
  • Surfactant-free and does NOT contain drying agents, such as ethyl alcohol

‡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, and propane).10

ZILXI OFFERS FIRST-LINE EFFICACY AGAINST ROSACEA IN THE ONLY TOPICAL MINOCYCLINE FOAM

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EFFICACY
IMPORTANT SAFETY INFORMATION

Contraindications

Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in ZILXI.

Warnings and Precautions

Flammability: The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

ZILXI is a topical foam. While systemic absorption of ZILXI is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:

  • Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
  • Clostridioides difficile associated diarrhea (CDAD): If CDAD occurs, discontinue ZILXI.
  • Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue ZILXI.
  • Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery.
  • Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue ZILXI immediately if symptoms occur.
  • Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue ZILXI immediately if symptoms occur.
  • Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using ZILXI. Advise patients to discontinue treatment with ZILXI at the first evidence of sunburn.
  • Hypersensitivity reactions: Discontinue ZILXI immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
  • Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
  • Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue ZILXI and institute appropriate therapy.

Adverse Reactions

The most common adverse reaction reported during clinical trials of ZILXI was diarrhea.

Indications and Usage

ZILXI (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.

Please click to access full Prescribing Information.

IMPORTANT SAFETY INFORMATIONOrange arrow

Contraindications

Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in ZILXI.

Warnings and Precautions

Flammability: The propellant in ZILXI is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

ZILXI is a topical foam. While systemic absorption of ZILXI is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:

  • Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
  • Clostridioides difficile associated diarrhea (CDAD): If CDAD occurs, discontinue ZILXI.
  • Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue ZILXI.
  • Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery.
  • Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue ZILXI immediately if symptoms occur.
  • Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue ZILXI immediately if symptoms occur.
  • Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using ZILXI. Advise patients to discontinue treatment with ZILXI at the first evidence of sunburn.
  • Hypersensitivity reactions: Discontinue ZILXI immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
  • Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
  • Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue ZILXI and institute appropriate therapy.

Adverse Reactions

The most common adverse reaction reported during clinical trials of ZILXI was diarrhea.

Indications and Usage

ZILXI (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.

Please click to access full Prescribing Information.

REFERENCES

  1. Sapadin AN, et al. J Am Acad Dermatol. 2006;54(2):258-265.
  2. Mrowietz U, et al. Am J Clin Dermatol. 2018;19(3):427-436. doi: 10.1007/s40257-017-0339-0.
  3. Rivero AL, Whitfeld M. Aust Prescr. 2018;41(1):20‐24. doi: 10.18773/austprescr.2018.004.
  4. Jones TM, et al. J Drugs Dermatol. 2017;16(10):1022-1028.
  5. Hazot Y, et al. J Anal Pharm Res. 2017;4(5):00117.
  6. Tamarkin D. Foam: a unique delivery vehicle for topically applied formulations. In: Dayan N, ed. Handbook of Formulating Dermal Applications: A Definitive Practical Guide. Beverly, MA: Scrivener Publishing LLC; 2017:233-260.
  7. Moribe K, et al. Chem Pharm Bull. 2010;58(8):1096-1099.
  8. Yokota J, et al. J Chin Med Assoc. 2018;81(6):511-519.
  9. Tamarkin D, et al. Expert Opin Drug Deliv. 2006;3(6):799-807.
  10. ZILXI™ (minocycline) topical foam, 1.5% Prescribing Information. Scottsdale, AZ: Journey Medical Corporation; 2022.
  11. Lin TK, et al. J Mol Sci. 2017;19(1):70. doi: 10.3390/ijms19010070.
  12. Stein Gold L, et al. J Am Acad Dermatol. 2020;82(5):1166-1173. doi: 10.1016/j.jaad.2020.01.043.
  13. Stein Gold L, et al. Open-label extension study evaluating the long-term safety, efficacy, and tolerability of FMX103 1.5% topical minocycline foam in the treatment of moderate-to-severe facial papulopustular rosacea. Poster presented at: 39th Annual Fall Clinical Dermatology Conference®; October 17-20, 2019; Las Vegas, Nevada.
  14. Del Rosso JQ, et al. Integrated summary of efficacy of FMX103 1.5% topical minocycline foam for the treatment of moderate-to-severe papulopustular rosacea: results from two Phase 3 studies. Poster presented at: 17th Annual South Beach Symposium in Dermatology; February 6-9, 2020; Miami, Florida.
  15. Data on file. Journey Medical Corporation.
  16. Jones TM, et al. SKIN J Cutan Med. 2019;3(2). doi: 10.25251/skin.3.2.2.
  17. Stein Gold L, et al. Integrated safety analysis of FMX103 1.5% topical minocycline foam for the treatment of moderate-to-severe papulopustular rosacea (PPR): results from two Phase 3 studies. Poster presented at: American Academy of Dermatology Annual Meeting; March 20-24, 2020; Denver, CO. Poster No. 13509.

Foamix Pharmaceuticals is a wholly owned subsidiary of VYNE Therapeutics Inc.

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