| “Rosacea is a difficult-to-treat skin condition, and based on the favorable results from our phase 3 clinical trials, Emrosi has the potential to become the best-in-class oral medication to treat the condition.” Mr. Claude Maraoui CEO |
| “Emrosi showed great efficacy and tolerability in the pivotal clinical trials, and we are tremendously grateful to everyone who participated and contributed to this important approval milestone.” Dr. Srinivas Sidgiddi Vice President of Research and Development at Journey Medical |
Journey Medical (DERM.O) announced that the U.S. Food and Drug Administration (FDA) has approved its drug, Emrosi (minocycline hydrochloride extended-release capsules 40mg), for the treatment of inflammatory lesions associated with rosacea (a long-term skin condition) in adults. Rosacea, a chronic skin condition affecting over 16 million people in the United States, is characterized by deep facial redness, small pus-filled bumps on the face, acne-like inflammatory lesions, and visible blood vessels. It is often classified into four types and can significantly impact patients’ self-esteem and social interactions.
However, shares of the company fell nearly 14% as the regulator approved the drug to treat inflammation associated with the condition, and not for reducing redness, also known as erythema.
| Erythema |
| A general term for skin redness that can be caused by a number of factors, including sunlight, alcohol, and stress. Erythema multiforme is a skin disorder that causes symmetrical, raised, red areas of skin that can appear anywhere on the body, but are most noticeable on the fingers and toes. |
| Rosacea |
| A non-contagious, chronic skin condition that causes inflammation and redness of the face. Rosacea is characterized by enlarged capillaries, which can give the appearance of a permanent flush. The forehead, cheeks, and chin may also develop yellow-headed pimples. Rosacea can be categorized into four different types, including erythematotelangiectatic rosacea (ETR), which causes skin redness, flushing, and spider veins. |
The most common adverse event was dyspepsia, reported by ≥ 1% of patients treated with the approved minocycline hydrochloride extended release capsules.
Price Of Drug
Journey Medical stated that Emrosi is expected to be commercially available to U.S. patients by late in the first quarter or early in the second quarter of 2025. The company plans to disclose Emrosi’s pricing closer to its launch, with expectations that it would be “relatively in the same area” as Oracea’s price, which is approximately $950 a month. Galderma did not immediately respond to requests for information regarding Oracea’s pricing The FDA’s approval was based on two late-stage clinical trials, MVOR-1 and MVOR-2, where Emrosi met all primary and secondary endpoints after 16 weeks of treatment, with no significant safety issues reported.
The drug demonstrated statistically significant superiority over both Galderma’s Oracea and a placebo in terms of treatment success as assessed by the Investigator’s Global Assessment and in reducing the total count of inflammatory lesions.
| Surveys from the National Rosacea Society | |
| Psychological impact of Disease | Percentage of Patients |
| Decreased self-confidence and self- esteem | 90% |
| Avoided social interactions or canceled plans | 41% |
| Adversely affected their professional interactions | 88% |
| Missed their work | 51% |
In summary, while the FDA’s approval of Emrosi marks a significant advancement in the treatment options for rosacea, the market’s initial reaction highlights the complexities and expectations surrounding new drug approvals. Journey Medical remains committed to providing innovative solutions for patients suffering from dermatological conditions.
The Medical Bulletin
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