Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules, 40 mg), formerly known as DFD-29, has received FDA approval for the treatment of inflammatory lesions of rosacea in adults. This approval marks a significant advancement in the treatment of rosacea, a chronic skin condition affecting over 16 million Americans and 415 million people globally.
The approval is based on data from two Phase 3 clinical trials, MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455). These trials were 16-week, multicenter, randomized, double-blind, controlled studies comparing Emrosi (40 mg) to doxycycline capsules (40 mg) and placebo. Approximately 320 subjects at least 18 years old diagnosed with moderate to severe papulopustular rosacea were enrolled in each study.
Clinical Trial Results
The clinical trials demonstrated that Emrosi was more effective than both Oracea (doxycycline 40 mg) and placebo in treating rosacea. Participants treated with Emrosi showed a higher success rate as assessed by the Investigator’s Global Assessment and a greater reduction in the total number of inflammatory lesions. The most common adverse event reported was dyspepsia, with no significant adverse effects observed.
Srinivas Sidgiddi, MD, vice president, research and development at Journey Medical, stated, "Emrosi showed great efficacy and tolerability in the pivotal clinical trials, and we are tremendously grateful to the patients, physicians, investigators, and site coordinators who participated and contributed to this important approval milestone."
Impact on Rosacea Patients
Rosacea is characterized by recurring inflammation, leading to symptoms such as deep facial redness, acne-like inflammatory lesions, and spider veins. The National Rosacea Society reports that over 90% of rosacea patients experience a decrease in self-confidence and self-esteem, with 41% avoiding social interactions due to their condition.
Claude Maraoui, co-founder, president, and chief executive officer of Journey Medical, commented, "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 3 clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition."
Availability
Journey Medical is currently finalizing the production of Emrosi for the US market and anticipates initial supplies to be available in late Q1 or early Q2 2024. The company plans to commercialize the therapy through its dermatology-focused commercial organization, aiming to establish Emrosi as the new oral standard of care for rosacea.
