FDA Approves Journey Medical’s DFD-29 for Rosacea

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Journey Medical Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved minocycline hydrochloride, 40 mg extended release capsules (Emrosi) for the treatment of erythema and inflammatory lesions in adult patients with rosacea.¹ The New Drug Application was submitted earlier this year and met the FDA’s anticipated Prescription Drug User Fee Act goal date.²

The approval is supported by positive data from 2 phase 3 clinical trials, MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455).³ Each clinical trial achieved its established primary and secondary endpoints. In patients with rosacea, DFD-29 exhibited statistical significance via Investigator's Global Assessment treatment success, a reduction in the total number of inflammatory lesions, and a reduction in Clinician's Erythema Assessment. 

Participants completed the 16-week treatment with no significant adverse effects. The most common adverse event was dyspepsia, reported by ≥ 1% of patients treated with the approved minocycline hydrochloride extended release capsules. The drug, commonly referred to as DFD-29, exhibited superiority over both placebo treatment and 40 mg Oracea (doxycycline) tablets.

In a statement, Srinivas Sidgiddi, MD, Vice President of Research & Development at Journey Medical, said, “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.”

With this approval, DFD-29 is the only oral, systemic therapy approved to address both erythema and inflammatory lesions associated with rosacea, making it a best-in-class therapeutic option for these symptoms. Journey Medical anticipates that the drug will be available late in the first quarter or early in the second quarter of 2025.

“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, Emrosi has potential to become the best-in-class oral medication to treat the condition.” said Claude Maraoui, co-founder, president, and chief executive officer of Journey Medical, in a press release. “Our seasoned 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 is committed to bringing cutting-edge innovation to patients with dermatological conditions and the healthcare professionals who treat them.”

References

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

3. Journey Medical Corporation. Journey Medical Corporation submitsNew Drug Application to FDA for DFD-29 to treat rosacea. GlobeNewswire News Room. January 5, 2024. Accessed November 4, 2024. https://www.globenewswire.com/news-release/2024/01/05/2804636/0/en/Journey-Medical-Corporation-Submits-New-Drug-Application-to-FDA-for-DFD-29-to-Treat-Rosacea.html