Journey Medical Corporation, a leading biopharmaceutical company dedicated to the development and commercialization of innovative dermatology treatments, has announced that the US Food and Drug Administration (FDA) has approved Emrosi (minocycline hydrochloride extended release capsules, 40 mg), formerly referred to as DFD-29, for the treatment of rosacea.
According to the National Rosacea Society (NRS), rosacea is a chronic inflammatory skin condition that is estimated to affect over 16 million individuals in the US and up to 415 million worldwide.
It is characterized by facial redness, swelling, visible blood vessels and, in some cases, small, red, pus-filled bumps that give an acne-like appearance. This can have significant effects on emotional well-being and self-esteem.
According to surveys conducted by the NRS, over 90 percent of rosacea patients reported that the condition had negatively impacted their self-confidence and self-esteem, while 41 percent stated it led them to avoid social situations or cancel plans. Among those with severe symptoms, 88 percent noted that rosacea had affected their professional interactions, and 51 percent said they had missed work due to their condition.
Despite the prevalence of rosacea, effective treatment options have been limited, and there has been a significant unmet need for innovative therapies that address both the inflammatory and bacterial aspects of the disease.
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Emrosi consists of minocycline, a tetracycline antibiotic, to target bacterial infection that can underlie rosacea. Research suggests that certain bacteria, particularly those associated with Demodex mites (tiny mites that naturally live on human skin) like Bacillus oleronius, could contribute to rosacea in some individuals. Other studies suggest that Helicobacter pylori bacteria infections may also cause rosacea.
Galderma’s doxycycline drug Oracea (doxycycline 40 mg capsules) is the current standard-of-care treatment for rosacea.
Emrosi’s approval was based on data from a pair of Phase III clinical trials for the treatment of rosacea. The trials met all co-primary and secondary endpoints, with participants having successfully completed the 16-week treatment with no significant safety issues.
Emrosi demonstrated statistically significant superiority over Oracea and placebo, as well as a reduction in total inflammatory lesion count in both studies.
According to Journey, Emrosi also demonstrated significant reductions in erythema (redness) and other patient-reported symptoms compared to placebo. The company reported that patients using Emrosi experienced improved skin clarity, with visible results as early as four weeks into treatment. The safety and tolerability profile of Emrosi was also favorable, with minimal side effects reported.
Claude Maraoui, co-founder, president and CEO of Journey Medical, said, “With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the US suffering from rosacea. Rosacea is a difficult-to-treat skin condition, and based on the favorable results from our Phase III clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition.”
Maraoui said the company’s dermatology-focused sales force is “now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.”
Journey Medical plans to make Emrosi available by early 2025 through dermatology clinics and pharmacies across the US. The treatment will be available in both a prescription-only format and through specialty dermatology providers who can provide personalized patient guidance and support.
Alongside Oracea, Journey’s rosacea treatment could compete with Sol-Gel Technologies’ Epsolay (benzoyl peroxide) cream, five percent, a topical medication developed in partnership with Galderma that received approval in 2022. The treatment uses Sol-Gel’s microencapsulation technology with benzoyl peroxide, allowing for a controlled, slow release of the active ingredient to reduce skin irritation.
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