Journey Medical Submits NDA to FDA for DFD-29 Rosacea Treatment
Key Insights
Journey Medical has submitted a New Drug Application (NDA) to the FDA for DFD-29 for treating rosacea (search), specifically erythema (search) and inflammatory lesions.
The NDA is supported by positive Phase 3 clinical trial data, where DFD-29 showed statistically significant improvements in Investigator's Global Assessment and lesion reduction.
DFD-29 demonstrated superiority over placebo and Oracea (doxycycline) in clinical trials, with no significant safety concerns reported over the 16-week duration.
Journey Medical Corporation has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for DFD-29 (minocycline hydrochloride modified release capsules, 40 mg) for the treatment of erythema (search) and inflammatory lesions in adults with rosacea (search). The submission, a significant milestone for the company, is based on positive data from two Phase 3 clinical trials.
Phase 3 Trial Results
The Phase 3 clinical trials supporting the NDA achieved their primary and secondary endpoints. DFD-29 demonstrated statistically significant superiority over both placebo and Oracea (doxycycline 40 mg) in Investigator's Global Assessment (IGA) treatment success and reduction in total inflammatory lesion count. Furthermore, DFD-29 showed a statistically significant reduction in Clinician's Erythema (search) Assessment (CEA) compared to placebo in both trials, addressing the erythema (redness) associated with rosacea (search).
Potential as a Best-in-Class Treatment
According to Journey Medical, DFD-29 has the potential to become the only oral, systemic therapy approved to address both inflammatory lesions and erythema (search) associated with rosacea (search). Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated that DFD-29 could fundamentally improve the treatment paradigm for patients suffering from both inflammatory lesions and erythema from rosacea.
Rosacea and DFD-29
Rosacea (search) is a chronic inflammatory skin condition affecting approximately 16 million people in the United States. It is characterized by small, red, pus-filled bumps, redness, and visible blood vessels on the face. DFD-29, developed in collaboration with Dr. Reddy’s Laboratories Ltd. (search), offers a potential new treatment option for this condition.
Safety Profile
Over the 16-week trial durations, no significant safety signals were reported, suggesting a favorable safety profile for DFD-29.