Journey Medical Corp. has submitted a New Drug Application (NDA) to the FDA for its modified release formulation of minocycline for the treatment of inflammatory lesions and erythema of rosacea in adults. Journey Medical is developing DFD-29 (minocycline hydrochloride modified release capsules, 40mg) in collaboration with Dr. Reddy’s Laboratories Ltd.
The NDA submission is supported by positive data from Journey Medical’s 2 DFD-29 Phase 3 clinical trials for the treatment of rosacea, which achieved all co-primary and secondary endpoints. 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. On a secondary endpoint, DFD-29 showed statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials. No significant safety issues emerged with 16 weeks of treatment.
