Journey Medical Corporation Announces Successful Completion of Pre-NDA Meeting With FDA for Rosacea Treatment

Journey Medical Corporation recently announced it 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.

“We are encouraged by the pre-NDA meeting and the progress we have made towards our goal of securing the regulatory review and approval necessary to make DFD-29 available to patients. With all of the unique differentiators DFD-29 brings to the patient, it has the potential to become the best-in-class and the only oral, systemic therapy to address both inflammatory lesions and redness from rosacea, changing the treatment paradigm for this long-term inflammatory skin condition,” said Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical.

Srinivas Sidgiddi, MD, Vice President, Research & Development at Journey Medical, added “We anticipate the NDA for DFD-29 will be submitted to the FDA around year-end and our goal, pending FDA approval, is to achieve a label that portrays the efficacy and safety profile DFD-29 demonstrated during its clinical development.”

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.

Journey Medical Corporation (Nasdaq: DERM) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of US FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The company currently markets eight branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, AZ, and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the US Securities and Exchange Commission (SEC). For more information, visit www.journeymedicalcorp.com.