Journey Medical Corporation, a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (?FDA?)-approved prescription pharmaceutical products for the treatment of dermatological conditions, announced that the Company received the official meeting minutes from its pre-New Drug Application (?NDA?) meeting with the FDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) to treat rosacea in adults. DFD-29 is being developed in collaboration with Dr. Reddy?s Laboratories Ltd. The purpose of the meeting was to discuss the 505(b)(2) NDA submission plan for DFD-29 for the treatment of inflammatory lesions (papules and pustules) and erythema of rosacea. During the pre-NDA meeting and in the official meeting minutes,?the FDA agreed that the proposed data package is sufficient to support the NDA submission, which the Company continues to anticipate will occur around year-end of 2023.

Positive topline data from Journey Medical?s two DFD-29 Phase 3 clinical trials for the treatment of rosacea were reported in July 2023. The Phase 3 clinical trials achieved all co-primary and secondary endpoints and subjects completed the 16-week treatment with no significant safety issues. DFD-29 demonstrated statistical superiority over both the standard of care Oracea® 40 mg capsules and placebo for Investigator?s Global Assessment treatment success as well as the reduction in the total inflammatory lesion count in both studies.

On a secondary endpoint related to erythema (redness) assessment, DFD-29 showed significantly superior reduction in Clinicians Erythema Assessment (CEA) compared to placebo in both clinical trials.