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

Rhea-AI Summary

Journey Medical (NASDAQ: DERM) has announced the launch and first prescriptions of Emrosi™, a 40 mg Minocycline Hydrochloride Modified-Release Capsule treatment for inflammatory lesions of rosacea in adults. The medication, which received FDA approval in November 2024, is now available through specialty pharmacy chains.

Emrosi is the lowest-dose oral minocycline available, featuring a unique 10 mg immediate release and 30 mg extended release formulation. Clinical trials demonstrated superior efficacy compared to Oracea® and placebo while maintaining a comparable safety profile. The most common adverse reaction reported was dyspepsia, occurring in ≥1% of subjects.

Positive

• First-to-market with lowest-dose oral minocycline treatment for rosacea
• Superior clinical efficacy demonstrated versus Oracea® and placebo
• Successfully launched product with prescriptions already being filled
• FDA approval secured for large market opportunity (millions affected by rosacea)

Negative

• Multiple serious potential side effects and safety warnings could impact adoption
• Risk of antibiotic-resistant bacteria development may limit long-term use
• Requires ongoing safety monitoring and periodic laboratory evaluations

Insights

Pharmaceutical Industry Analyst

Journey Medical's launch of Emrosi for rosacea represents a significant commercial milestone for this small-cap specialty pharmaceutical company. With initial distribution to pharmacies underway and first prescriptions already filled, the company has successfully transitioned from the November 2024 FDA approval to commercial availability in approximately four months.

Emrosi's market positioning appears strategically sound. As the lowest-dose oral minocycline available, the product offers a differentiated profile in the rosacea treatment landscape. The company's clinical claim of superior efficacy compared to Oracea (a competing product) while maintaining a comparable safety profile provides a potential competitive advantage in prescriber discussions and payer negotiations.

For a company with a $116 million market capitalization, successful commercialization of new dermatology products is essential for growth. The rosacea market represents a substantial opportunity, affecting millions of adults in the US alone. Distribution through specialty pharmacy chains aligns with the product's prescription-only status and targeted dermatology focus.

While the announcement lacks specific revenue projections or market penetration targets, the successful execution of this product launch demonstrates operational capability in bringing FDA-approved assets to market. The commercial performance of Emrosi will depend on multiple factors including prescriber adoption, patient adherence, insurance coverage, and competitive response—all typical considerations for specialty pharmaceutical products in the current market environment.

Initial distribution of Emrosi to pharmacies ongoing

First prescriptions of Emrosi filled

SCOTTSDALE, Ariz., March 24, 2025 (GLOBE NEWSWIRE) -- 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 Medical 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 www.emrosi.com.

About Rosacea
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 Emrosi^TM 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.

Company Contact:
Jaclyn Jaffe
(781) 652-4500
ir@jmcderm.com

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com

FAQ

What are the clinical advantages of Emrosi (DERM) over existing rosacea treatments?

Emrosi is the lowest-dose oral minocycline available and showed significantly superior clinical outcomes compared to Oracea® and placebo in trials, while maintaining similar safety profile.

When did Journey Medical (DERM) receive FDA approval for Emrosi?

Journey Medical received FDA approval for Emrosi in November 2024 for treating inflammatory lesions of rosacea in adults.

What are the main safety concerns and contraindications for Journey Medical's Emrosi?

Key contraindications include tetracycline hypersensitivity, pregnancy risks, and potential for serious skin reactions. Patients should avoid sun exposure and monitor for possible side effects.

How is Journey Medical's Emrosi (DERM) administered for rosacea treatment?

Emrosi is a 40mg minocycline hydrochloride capsule combining 10mg immediate release and 30mg extended release, available by prescription through specialty pharmacies.