ZILXI is the First FDA Approved Minocycline Product for the Treatment of Inflammatory Lesions of Rosacea in Adults
ZILXI
demonstrated a favorable safety and tolerability profile for up to 52 weeks of treatment
Efficacy of ZILXI continued to develop for an additional 40 weeks of treatment after an initial treatment period of 12 weeks
BRIDGEWATER, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) announced today the peer reviewed publication of long-term safety and efficacy data for ZILXI™ (minocycline) topical foam, 1.5% in the Journal of Clinical and Aesthetic Dermatology (JCAD). Study FX2016-13 evaluated the safety and efficacy of ZILXI for up to 40 weeks of open-label treatment immediately following an initial 12-week double-blind treatment. This study was conducted by VYNE to support the New Drug Application (NDA) of ZILXI which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of inflammatory lesions of rosacea in adults in May of this year.
“Following the commercial launch of ZILXI in October, we are pleased that JCAD has accepted these long-term safety and efficacy data for publication,” said David Domzalski, CEO of VYNE. “We hope that ZILXI’s safety profile for long term treatment coupled with enduring efficacy will provide patients living with rosacea an attractive new option for lasting control of their disease.”
Highlights from the Long-Term Safety & Efficacy
in Study FX2016-13
:
Study FX2016-13 included a total of 504 patients in the all-treated population, all of whom had completed 12 weeks of ZILXI or vehicle treatment in one of two preceding double-blind phase 3 studies (Studies FX2016-11 or FX2016-12). Patients continued for up to an additional 40 weeks of open-label treatment with ZILXI.
410 patients completed participation in the study of which 332 patients had received a total of 52 weeks of ZILXI therapy which was in excess of the subject sample size requirements specified in the regulatory guidance for this type of safety evaluation (ICH E1A, 1995). 96.1% of patients participating in study FX2016-13 received a minimum of 26 weeks of ZILXI therapy. Key findings from the study are as follows:
- Non-dermal adverse events were comparable in type and frequency with those reported during the preceding 12-week double-blind studies. The most frequently reported treatment-emergent adverse event in this study was upper respiratory tract infection (common cold) (14 subjects). A total of 5 patients discontinued the study over the course of 40 weeks of treatment due to an adverse event and no serious drug-related adverse events were reported.
- In the assessment of facial dermal tolerability at Week 52, the majority of subjects (>57%) had no signs of burning/stinging, flushing/blushing, dryness/xerosis, itching, peeling/desquamation, or post-inflammatory hyperpigmentation. All facial local tolerability assessments made at Week 52 improved relative to assessments made at the study baseline of the preceding double-blind studies. In this regard, the percentage of patients with clear and almost clear erythema at study baseline of the preceding double-blind studies improved from 4.0% to 59.3% by the end of the open-label study.
- Long-term treatment with ZILXI was associated with a progressive decrease in inflammatory lesions and a parallel increase in the proportion of subjects achieving IGA treatment success. The overall mean percent change (reduction) from study baseline of the preceding double-blind studies when assessed at Week 52 was 82.3%. Equally, the proportion of subjects achieving Investigator Global Assessment (IGA) treatment success (IGA score of 0 “clear” or 1 “almost clear”) at week 52 was 79.8%.
- Subject satisfaction with ZILXI treatment continued to increase when re-assessed at Week 52 relative to Week 12 assessments made in the preceding double-blind studies. At Week 52, the majority of subjects (82.4%) reported being overall “satisfied” or “very satisfied” with ZILXI in treating their rosacea. The majority of subjects (83.2%) were also satisfied or very satisfied with how ZILXI compared with other products, as well as with its ease of use (92.9%). Most subjects (83.2%) reported being “likely” or “very likely” to recommend ZILXI to a friend.
“We are pleased that our comprehensive long-term safety and efficacy evaluation of ZILXI has been published in JCAD. ZILXI is well tolerated, with an acceptable safety profile and impressive long-term efficacy which are important factors in the treatment of chronic, relapsing dermatological conditions such as rosacea,” said Dr. Iain Stuart, Chief Scientific Officer of VYNE.
Indication
ZILXI (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, flame, 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 should not be 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 for 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 for 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 life.1 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 lesions.2
About VYNE Therapeutics Inc.
VYNE Therapeutics’ mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for AMZEEQ® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI™ (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at amzeeq.com and ZILXI’s Full Prescribing Information at zilxi.com.
For more information about VYNE Therapeutics Inc. or its investigational products, visit www. vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.
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Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization of AMZEEQ and ZILXI; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from VYNE’s clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ, ZILXI or any other products or product candidates that VYNE may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ and ZILXI prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ, ZILXI or any of VYNE’s other products or product candidates; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; VYNE’s ability to recruit and retain key employees; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.
- Aksoy, B., Altaykan‐Hapa, A., Egemen, D., Karagöz, F. and Atakan, N. (2010), The impact of rosacea on quality of life: effects of demographic and clinical characteristics and various treatment modalities. British Journal of Dermatology, 163: 719-725.
- Gether et al. Incidence and prevalence of rosacea: a systematic review and meta-analysis. British Journal of Dermatology 25 Feb 2018.179: 282-289.
