Journey Medical Corporation's minocycline hydrochloride modified-release capsules 40 mg (Emrosi), previously known as DFD-29, have received FDA approval for treating inflammatory lesions and erythema in adults with rosacea. This decision follows the FDA's acceptance of the company's new drug application (NDA) and favorable outcomes from two Phase 3 clinical trials evaluating the treatment's effectiveness in rosacea patients.
Rosacea, a chronic inflammatory skin condition affecting approximately 16 million people in the US, is characterized by redness, visible facial blood vessels, and small, pus-filled bumps.
Clinical Trial Results
The approval was supported by data from the Phase 3 MVOR-1 and MVOR-2 clinical trials. The trials randomized participants in a 3:3:2 ratio to receive either minocycline hydrochloride modified-release capsules, doxycycline capsules 40 mg (Oracea), or a placebo once daily for 16 weeks.
The primary objective of both trials was to evaluate the safety and efficacy of minocycline hydrochloride modified-release capsules compared to placebo in treating papulopustular rosacea. Secondary goals included assessing the drug's safety and efficacy in comparison to doxycycline.
Both clinical trials successfully met all co-primary and secondary endpoints. Results indicated that the proportion of individuals achieving Investigator’s Global Assessment (IGA) success in the minocycline hydrochloride modified-release capsules treatment group was statistically significantly higher than in the doxycycline and placebo groups.
Furthermore, the reduction in total inflammatory lesion count from baseline to week 16 was statistically superior in the minocycline hydrochloride modified-release capsules arm compared to the placebo and doxycycline arms. No major safety concerns or serious adverse events related to the study products were reported in either MVOR-1 or MVOR-2.
The number and severity of treatment-emergent adverse events (TEAEs) were comparable across all treatment groups. The types of TEAEs associated with the study products were also similar between the groups.
Impact on Erythema
Secondary endpoint analysis revealed that minocycline hydrochloride modified-release capsules led to a statistically significant reduction in erythema associated with rosacea, as measured by the Clinician’s Erythema Assessment (CEA), compared to placebo in both clinical studies.
Company Statements
Claude Maraoui, co-founder, president, and chief executive officer of Journey Medical, stated, “With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the U.S. suffering from rosacea. Rosacea is a difficult-to-treat skin condition, and based on the favorable results from our Phase 3 clinical trials, [minocycline hydrochloride modified release capsules have] the potential to become the best-in-class oral medication to treat the condition.”
Srinivas Sidgiddi, MD, the vice president of research & development at Journey Medical, added, “[Minocycline hydrochloride modified release capsules] 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.”
