The FDA has accepted the New Drug Application (NDA) from Journey Medical Corp. for DFD-29 (minocycline hydrochloride modified release capsules, 40mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. The PDUFA goal date is November 4, 2024.
Journey previously announced the NDA submission and reported positive Phase 3 trial results for DFD-29 in rosacea.
“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. DFD-29 demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment (IGA) treatment success as well as the reduction in the total inflammatory lesion count in both studies,” says Srinivas Sidgiddi, MD, Vice President, Research & Development at Journey Medical. “For the secondary endpoint evaluating erythema (redness) associated with rosacea, DFD-29 showed a statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials.”