Journey Medical Corporation has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (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.
“Based on the data seen in our pivotal trials, DFD-29 could fundamentally improve the treatment paradigm for patients suffering from both inflammatory lesions and erythema (redness) from rosacea,” says Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, in a news release.
The NDA submission is based on 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.
DFD-29 demonstrated statistical superiority over both the current standard-of-care treatment, 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 statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials.
