Journey Medical Corporation announced that the Company has submitted a New Drug Application to the FDA seeking approval for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. DFD-29 is being developed in collaboration with Dr. Reddy's Laboratories Ltd. The NDA submission is supported by positive data from Journey Medical's two DFD-29 Phase 3 clinical trials for the treatment of rosacea. The Phase 3 clinical trials achieved all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues.

On a secondary endpoint related to erythema (redness) assessment, DFD-29 showed statistically significant reduction in Clinician's Erythema Assessment compared to placebo in both clinical trials. DFD-29 has the potential to become the only oral, systemic therapy to address both inflammatory lesions and ery thema (redness) from rosacea, as demonstrated in the clinical trials.