VYNE Therapeutics Announces Covered Status for ZILXI™ (minocycline) with Express Scripts

VYNE Therapeutics announced a coverage update for its novel ZILXI™ (minocycline) topical foam, 1.5%. ZILXI is the first minocycline product of any form to be FDA approved for use in rosacea for the treatment of inflammatory lesions in adults and is just recently available in pharmacies nationwide.

Express Scripts, one of the nation’s leading pharmacy benefit managers (PBMs), has elected to cover ZILXI effective October 2, 2020 on Express Scripts’ National Preferred, Flex, and Basic commercial formularies, representing millions of additional covered lives in the U.S. that follow these formularies.

David Domzalski, Chief Executive Officer of VYNE Said: “The addition of Express Scripts to our national coverage for ZILXI is a significant milestone as it represents a large portion of the U.S. commercial coverage patient population, We are pleased that our contract provides access to this important new option for physicians and patients who have not previously had the rosacea treatment outcomes they are seeking.”

The annual list price of ZILXI is $485 per 30-gram canister. ZILXI was approved by the U.S. Food and Drug Administration in May 2020.

Minocycline is one of several broad-spectrum antibiotics known as tetracyclines with anti-inflammatory properties; their use in some patients is limited due to systemic side effects when taken orally. In ZILXI, VYNE has once more leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to effectively deliver minocycline in a foam-based vehicle that contains naturally moisturizing ingredients, such as coconut and soybean oil, and is free of surfactants and drying agents.

ZILXI Important Safety Information

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, which may be caused by an infection and can cause watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes (jaundice); 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.

About Rosacea

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 can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can adversely affect quality of life1. Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in the United States; up to 28% of these sufferers have rosacea with inflammatory lesions2.

Related Posts

Subscribe Our Newsletter