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 FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of November 4, 2024.
In Phase 3 clinical trials for rosacea, DFD-29 demonstrated statistical superiority over both doxcycline 40mg capsules (30mg immediate release/10mg delayed release) and placebo for Investigator’s Global Assessment treatment success as well as reduction in the total inflammatory lesion count in both studies. DFD-29 showed statistically significant reduction in Clinician’s Erythema Assessment (CEA, a secondary endpoint) compared to placebo in both clinical trials. No significant safety issues were identified.
“This is promising news for patients suffering from rosacea and we who treat them. With only one FDA-approved oral agent available to treat rosacea, we welcome novel therapeutic agents to help treat this patient population,” said Joe Gorelick, NP-C.
“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,” said Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical. “If approved, we believe that DFD-29 will be the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea, and will be a preferred treatment option by physicians and their patients to address the condition.”