VYNE Therapeutics Inc (VYNE)

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https://vynetherapeutics.com/press-releases/vyne-therapeutics-announces-zilxi-minocycline-topical-foam-1-5-is-available-in-pharmacies-nationwide-today-october-1st/

VYNE Therapeutics Announces ZILXI™ (minocycline) topical foam, 1.5% is Available in Pharmacies Nationwide Today, October 1st
ZILXI is the First FDA Approved Minocycline Product for the Treatment of Inflammatory Lesions of Rosacea in Adults

ZILXI Offers Efficacy with Low Systemic Absorption

BRIDGEWATER, N.J., Oct. 01, 2020 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that its novel ZILXI™ (minocycline) topical foam, 1.5% is available as of today, October 1, 2020 by prescription for the treatment of inflammatory lesions of rosacea in adults. Approved by the U.S. Food and Drug Administration (FDA) in May 2020, ZILXI is the first minocycline product of any form to be approved by the FDA for use in rosacea, 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). This new once-daily therapy will be available in retail, community and specialty pharmacies nationwide.

“Patients and physicians have been seeking new treatment options for rosacea, a condition that can be difficult to treat, leaving many patients dissatisfied and, in some cases, switching treatments multiple times or discontinuing altogether,” said David Domzalski, Chief Executive Officer of VYNE. “By combining a unique topical delivery system for minocycline with strong efficacy and tolerability, ZILXI is positioned to address a very challenging skin condition in a way that could change treatment considerations for rosacea.”

The Company also announced that the annual list price of ZILXI will be $485 per 30-gram canister, in parity with the wholesale price of AMZEEQ® (minocycline) topical foam, 4%, the Company’s topical minocycline indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. The Company is working to align contracts with commercial insurers, expanding efforts previously undertaken for AMZEEQ, to offer the broadest possible access to ZILXI for patients and healthcare professionals.

VYNE has also developed a multi-channel tactical marketing plan to reach customers, including deployment of the existing sales force to targeted rosacea-treating providers.

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 and AMZEEQ Important Safety Information

Indications
ZILXITM (minocycline) topical foam, 1.5% is for the treatment of adults with pimples and bumps caused by a condition called rosacea. It is not known if ZILXI is safe and effective in children.

AMZEEQ® (minocycline) topical foam, 4% is for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients 9 years age and older. It is not known if AMZEEQ is safe and effective in children under 9 years of age or older.

ZILXI and AMZEEQ are both topical forms of the antibiotic minocycline and are available by prescription only. ZILXI and AMZEEQ are for use on skin only (topical use). ZILXI and AMZEEQ are not for use in the mouth, eyes or vagina.