Menlo Therapeutics (NASDAQ: $MNLO) has just announced successful FDA approval of its FMX103 product, aptly named ZILIXI. This will be the first FDA approved topical Minocycline product for the treatment of Rosacea.
ZILXI will provide patients with a novel way of utilizing their medication, instead of taking Minocycline by mouth patients will be able to apply to their affected area.
Menlo Therapeutics now has two FDA approved drugs, both of which came out this year. Coupled with the fact that the firm has entered into a recent deal with a Chinese distributor, the future of the firm looks promising.
ZILXI will be available for prescribing by Q4 2020.
The National Rosacea Society (NRS) estimates 16 million Americans suffer from complications associated with Rosacea. According to Dr. Jonathan Wilkin, chairman of the NRS medical advisory board, in most cases Rosacea first appears during middle age which has taken the Baby Boomer generation by the storm. Considering Rosacea is a chronic condition, patients require constant medical therapy and care.
$MNLO’s price has been trending down after the FDA approval announcement which could however, be fully or partly explained by the following factors:
- The FDA approval may have already been priced into the stock, considering the 132.04% increase since April 3rd and a current market cap of $325.65M.
- Investors may have opted to secure their profits.
- It may be a typical weekend risk-off situation.
- Menlo Therapeutics expects ZILXI to be ready to market by Q4 2020, which may have been why investor’s became antsy and existed their positions.
- Could also be a typical market irrationality – such as the ZOOM frenzy:
Where investors purchased shares of Zoom Technologies (OTC: $ZOOM) instead of Zoom Video Communications Inc. (NASDAQ: $ZM) – pushing the OTC stock to a peak of 1800% while the real deal Zoom Video Communications Inc. ‘only’ enjoyed a 132% appreciation. The SEC had to intervene and halt trading to clear up investors’ confusion.
Similar to Menlo Therapeutics, Aquestive Therapeutics Inc. (NASDAQ: $AQST) experienced a depreciation in share price after Sunovian Pharmaceuticals’ was granted FDA approval for its Kynmobi drug in the treatment of Parkinson’s disease.
Nevertheless, Menlo Therapeutics could have a very positive long-term outlook considering their pipeline developments, and now two FDA approved drugs ready to market.
Read more here why Menlo Therapeutics (NASDAQ: $MNLO) should be on your radar.
Menlo Therapeutics Receives FDA Approval of ZILXI™ (minocycline) topical foam, 1.5%, the First Topical Minocycline Treatment for Rosacea
BRIDGEWATER, N.J., May 29, 2020 (GLOBE NEWSWIRE) — Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved ZILXI™ (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. ZILXI, developed as FMX103 by Menlo’s wholly-owned subsidiary Foamix Pharmaceuticals Ltd. (“Foamix”), is the first minocycline product of any kind to be approved by the FDA for use in rosacea.
“This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder,” said David Domzalski, Chief Executive Officer of Menlo. “ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective.”
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).
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, Menlo has once more leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to effectively deliver minocycline in a foam-based vehicle.
“This is the only product containing minocycline approved by the FDA for rosacea,” said Iain Stuart, PhD, Chief Scientific Officer of Menlo. “The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions.”
The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older. In each 12-week multicenter, randomized, double-blind, vehicle-controlled trial, subjects with inflammatory lesions of rosacea were treated once daily with ZILXI or vehicle. No other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials. The co-primary efficacy endpoints were (a) the absolute change from baseline in inflammatory lesion counts at Week 12 and (b) the proportion of subjects with treatment success at Week 12 defined as an IGA score of 0 (“clear”) or 1 (“almost clear”), and at least a two-grade improvement (decrease) from baseline at Week 12. ZILXI met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. No treatment-related serious adverse events were reported. The most common adverse reaction reported by ≥1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs. 0%), respectively.
Menlo anticipates having ZILXI available for prescribing by 4th quarter of this year.
INDICATIONS AND USAGE
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 is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea, including watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes; 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.
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.