Journey Medical Corporation, announced that the Company has submitted, a New Drug Application (“NDA”) to the FDA seeking approval for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. DFD-29 is being developed in collaboration with Dr. Reddy’s Laboratories Ltd.
“This NDA submission is a significant milestone for Journey Medical and we look forward to collaborating with the FDA during its review to bring DFD-29, a potentially differentiated, best-in-class oral rosacea treatment, one step closer to patients. Based on the data seen in our pivotal trials, DFD-29 could fundamentally improve the treatment paradigm for patients suffering from both inflammatory lesions and erythema (redness) from rosacea,” said Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical.
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 statistical superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment treatment success as well as the reduction in the total inflammatory lesion count in both studies. On a secondary endpoint related to erythema (redness) assessment, DFD-29 showed statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials.
Rosacea, which affects approximately 16 million people in the United States according to the National Rosacea Society, is a long-term, inflammatory skin condition that causes small, red, pus-filled bumps, redness and visible blood vessels in the face. DFD-29 has the potential to become the only oral, systemic therapy to address both inflammatory lesions and erythema (redness) from rosacea, as demonstrated in the clinical trials.
Ref : https://en.wikipedia.org/wiki/Minocycline
No comments:
Post a Comment