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Journey Medical Corporation Launches Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) for the Treatment of Rosacea Initial distribution of Emrosi to p

Key Takeaway: Journey Medical Corporation has officially launched Emrosi, a modified-release capsule formulation of minocycline hydrochloride for treating inflammatory lesions of rosacea. The initial distribution to pharmacies has commenced, and the first prescriptions have been filled. Emrosi has received FDA approval and is noted for delivering superior clinical outcomes compared to existing treatments. However, it comes with warnings regarding potential adverse reactions and serious health risks for some patients.

Market Sentiment Analysis

POSITIVE FACTORS

  • Launch of Emrosi marks a major milestone for Journey Medical.
  • Emrosi shows significantly superior clinical outcomes for rosacea.
  • Initial distribution and first prescriptions filled indicate strong market entry.
  • The product is the lowest-dose oral minocycline available for treatment.

CONCERNS & RISKS

  • Common adverse reactions include dyspepsia.
  • Potential serious side effects such as anaphylaxis and DRESS syndrome.
  • Risk of hyperpigmentation and other serious skin reactions with use.
  • Concerns regarding the development of antibiotic-resistant bacteria.

Full Press Release Details

Journey Medical Corporation Launches Emrosi
(40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) for the Treatment of Rosacea
Initial distribution of Emrosi to pharmacies
First prescriptions of Emrosi filled
Scottsdale, AZ - March 24, 2025 -
Journey Medical Corporation (Nasdaq: DERM) ("Journey Medical"), a commercial-stage pharmaceutical company that primarily focuses
on selling and marketing U.S. Food and Drug Administration ("FDA")-approved prescription pharmaceutical products for the treatment
of dermatological conditions, today announced the launch of and the first prescriptions filled for Emrosi (40 mg Minocycline Hydrochloride
Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) for the treatment of inflammatory lesions of rosacea in
adults. Emrosi is available by prescription at specialty pharmacy chains.
Claude Maraoui, Co-Founder,
President and Chief Executive Officer of Journey Medical, said, "We are thrilled that the initial distribution to pharmacies is
ongoing and the first Emrosi prescriptions have been filled. Rosacea is a challenging condition that affects millions, and Emrosi, the
lowest-dose oral minocycline on the market, delivers significantly superior clinical outcomes for rosacea compared to Oracea and
placebo, while maintaining a comparable safety profile, as demonstrated in clinical trials. The launch of Emrosi marks a major milestone
for Journey and underscores our commitment to improving the quality of life for those living with dermatology conditions such as rosacea."
The FDA approved Emrosi for the treatment of inflammatory
lesions of rosacea in adults in November 2024.
Important Safety Information
Indication: EMROSI is indicated
for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Adverse Events: The most common
adverse reaction reported by 1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. Contraindications: EMROSI
should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Warnings/Precautions: Cases
of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic
symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized,
discontinue EMROSI immediately. 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 and reversible inhibition of bone growth. Discontinue EMROSI use if Antibiotic-Associated
Colitis occurs. Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should
be cautioned about driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia,
and vision loss. Discontinue EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise.
Discontinue EMROSI immediately if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while
using EMROSI. Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs,
including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant
bacteria to develop during the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute
appropriate therapy. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You
are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
For full prescribing information, please visit
Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like
inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it
is estimated that rosacea affects over 16 million Americans and as many as 415 million people worldwide. Rosacea is most frequently
seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report that more than 90 percent
of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated that it had caused them
to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely
affected their professional interactions, and 51 percent said they had missed work because of their condition.
About Journey Medical Corporation
Journey Medical Corporation (Nasdaq: DERM) ("Journey
Medical") is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription
pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently
markets eight branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry
experts with extensive experience in developing and commercializing some of dermatology's most successful prescription brands.
Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical's common
stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and
Exchange Commission ("SEC"). For additional information about Journey Medical, visit www.journeymedicalcorp.com.
Forward-Looking Statements
This press release may contain "forward-looking
statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. As used below and throughout this press release, the words "the Company", "we", "us"
and "our" may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth
strategy and product development programs and any other statements that are not historical facts. The words "anticipate,"
"believe," "estimate," "may," "expect," "will," "could," "project,"
"intend," "potential" and similar expressions are generally intended to identify forward-looking statements. Forward-looking
statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect
our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from
those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation
and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive
from products that are without patent protection and/or are, or may become, subject to third-party generic competition, the introduction
of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse
impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation
or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products
and any setback relating to the sale of such products could impair our operating results; competition could limit our products'
commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that
our products do not achieve broad market acceptance, including by government and third-party payors; our reliance on third parties for
several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate
them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance
our company and generate additional revenue, on the successful commercialization EmrosiTM and the successful development, regulatory
approval and commercialization of any future product candidates that we may develop, in-license or acquire; clinical drug development
is very expensive, time consuming, and uncertain and any clinical trials we may initiate for future product candidates may fail to adequately
demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products
similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient
patent protection for our technology and products; our business and operations would suffer in the event of computer system failures,
cyber-attacks, or deficiencies in our or our third parties' cybersecurity; the effects of major public health issues, epidemics
or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; the substantial doubt
expressed about our ability to continue as a going concern; Fortress controls a voting majority of our common stock, which could be detrimental
to our other stockholders; as well as other risks described in Part I, Item 1A, "Risk Factors," in our Annual Report on Form
10-K for the year ended December 31, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim
any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect
any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may
be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995.
Media Relations Contact:

Frequently Asked Questions

What is Emrosi used to treat?

Emrosi is indicated for the treatment of inflammatory lesions of rosacea in adults.

What is the formulation of Emrosi?

Emrosi contains 40 mg Minocycline Hydrochloride in modified-release capsules.

When was Emrosi first approved by the FDA?

Emrosi received FDA approval for rosacea treatment in November 2024.

Where can Emrosi be prescribed?

Emrosi is available by prescription at specialty pharmacy chains.

What are common side effects of Emrosi?

The most common side effect reported was dyspepsia in 1% of patients.

Last updated: Mar 24, 2025