The U.S. Food and Drug Administration (FDA) has accepted Journey Medical’s New Drug Application (NDA) for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of November 4, 2024.
“We are pleased that the FDA has set a PDUFA date of November 4, 2024 for DFD-29, and we look forward to collaborating with the agency throughout the review process in order to bring this unique treatment option to patients suffering from rosacea,” says Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, in a news release. “If approved, we believe that DFD-29 will be the only oral medication to address both inflammatory lesions and erythema from rosacea, and will be a preferred treatment option by physicians and their patients to address the condition.”
Srinivas Sidgiddi, MD, Vice President, Research & Development at Journey Medical, adds, “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. 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.”
