Journey’s Rosacea Therapy Clears Pre-NDA Hurdle

The company is on track to submit an NDA to the FDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) to treat rosacea at the end of the year.

Journey Medical Corporation has successfully completed its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) to treat rosacea.

The company is on track to submit an NDA to the FDA for DFD-29 around year-end of 2023. 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 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.

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.

“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,” says Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, in a news release.

Srinivas Sidgiddi, MD, Vice President, Research & Development at Journey Medical, adds, “We anticipate that 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.”