FDA Approves Minocycline Hydrochloride Extended Release Capsules for Individuals with Rosacea

The US Food and Drug Administration (FDA) approval of minocycline hydrochloride modified release capsules 40 mg (Emrosi), formerly known as DFD-29, has been announced by Journal Medical Corporation, with the drug indicated for treatment of inflammatory lesions and erythema among adults with rosacea.¹

The approval follows the recent acceptance of the company’s new drug application (NDA) for minocycline hydrochloride extended release capsules and positive findings resulting from 2 phase 3 clinical studies assessing this treatment for patients with rosacea.² Rosacea itself a long-term, inflammatory skin disease which leads to redness, visible facial blood vessels, and small, red, pus-filled bumps, impacting approximately 16 million people in the US.

“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,” Claude Maraoui, co-founder, president, and chief executive officer of Journey Medical, said in a statement. “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.”¹

The drug results among individuals with rosacea followed the phase 3 MVOR-1 and MVOR-2 clinical studies. During these trials, those participating were randomized in a 3:3:2 ratio to be treated with minocycline hydrochloride modified release capsules, doxycycline capsules 40 mg (Oracea), or placebo once-per-day for a course lasting 16 weeks.²

Both clinical trials’ main objective was to assess minocycline hydrochloride modified release capsules’ safety and efficacy compared to placebo for papulopustular rosacea treatment. In terms of secondary goals, the 2 trials’ investigators sought to assess the safety and efficacy of the drug and compare it to doxycycline.

The clinical trials were successful in their achievement of all co-primary and all secondary endpoints. The research team concluded that the proportion of individuals achieving Investigator’s Global Assessment (IGA) success in the minocycline hydrochloride modified release capsules treatment cohort was shown to be statistically superior to those in the doxycycline and placebo cohorts.

In addition, the investigators found that the reduction in subjects’ total inflammatory lesion count from the point of baseline to the 16-week mark among those in the minocycline hydrochloride modified release capsules arm was noted as statistically superior to that of the placebo and doxycycline arms. The team added that there were no major safety issues and no serious adverse events associated with the study products in both MVOR-1 and MVOR-2.

Between the cohorts, the number of treatment emergent adverse events and their levels of severity were found to be comparable. TEAEs connected to the study products were also shown to be similar by the investigators between the cohorts.

In terms of secondary endpoints, erythema linked to rosacea showed reductions with those treated with minocycline hydrochloride modified release capsules. They had a statistically significant reduction in Clinician’s Erythema Assessment (CEA) versus placebo in both clinical studies.

“(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,” Srinivas Sidgiddi, MD, the vice president of research & development at Journey Medical, said in a statement.¹

References

1. ^{Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea. News release. Journey Medical Corporation. November 4, 2024. https://www.globenewswire.com/en/news-release/2024/11/04/2973917/0/en/Journey-Medical-Corporation-Announces-U-S-FDA-Approval-of-Emrosi-Minocycline-Hydrochloride-Extended-Release-Capsules-40-mg-for-the-Treatment-of-Rosacea.html.}
2. ^{Journey Medical Corporation announces US FDA acceptance of new drug application for DFD-29 for the treatment of rosacea. News release. Journey Medical Corporation. March 18, 2024. https://ir.journeymedicalcorp.com/new-events/press-releases/detail/61/journey-medical-corporation-announces-u-s-fda-acceptance. Date accessed: November 4, 2024.}