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ABOUT ZILXI

ENABLED BY MINOCYCLINE AND MOLECULE STABILIZING TECHNOLOGY (MST)™

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THE POWER OF MINOCYCLINEOUR PROPRIETARY VEHICLE

THE POWER OF MINOCYCLINE

Minocycline has been shown to exhibit anti-inflammatory properties*

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The Advantages of Minocycyline

Minocycline has been proven to be effective in the fight against inflammatory lesions of rosacea for the first time with Zilxi

  • Minocycline has been shown to exhibit potent anti-inflammatory properties1*
  • The 1.5% concentration of minocycline was found to be the clinically appropriate dose for treating inflammatory lesions of rosacea2†
Icon style drawing of a broken blue pill. Orange arrows are coming out from inside the pill, pointing down

The Challenges with Oral Minocycline

Oral tetracyclines are a mainstay in rosacea treatment. This is thought to be due to their anti-inflammatory properties.3* However, oral tetracyclines come with challenges

  • Oral minocycline is associated with high systemic exposure4
  • Minocycline has proven difficult to stabilize in a topical formulation because it is sensitive to light and oxidation and degrades upon contact with water and other protic solvents5

*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% in comparison with vehicle. While both doses of topical minocycline were superior to vehicle in reduction of inflammatory lesions and in improving subjects’ Investigator’s Global Assessment (IGA) scores, no additional clinical benefit for topical minocycline foam 3% was observed compared to topical minocycline foam 1.5%.2

ZILXI is clinically efficacious WITH A LOW RATE OF systemic side effects

OUR PROPRIETARY VEHICLE

Zilxi is enabled by a proprietary foam vehicle that leverages Molecule Stabilizing Technology (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

Formulated for efficiency

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

The foam vehicle is surfactant-free and does NOT contain drying agents, such as ethyl alcohol10

‡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).10

Zilxi is the first form of minocycline approved for the treatment of INFLAMMATORY LESIONS OF ROSACEA IN ADULTS

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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. Bridgewater, NJ: Foamix Pharmaceuticals Inc; 2020.
  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. Foamix Pharmaceuticals Inc.
  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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