The filing is supported by positive phase 3 clinical trial data.
Journey Medical Corporation announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for oral DFD-29 for the treatment of erythema and inflammatory lesions in patients with rosacea.
DFD-29, or minocycline hydrochloride modified release capsules, are being developed in collaboration with Dr. Reddy's Laboratories Ltd.
The filing is supported by positive data from 2 phase 3 clinical trials.
Each clinical trial achieved its established primary and secondary endpoints. In patients with rosacea, DFD-29 exhibited statistically significance via Investigator's Global Assessment treatment success, a reduction in the total number of inflammatory lesions, and a reduction in Clinician's Erythema Assessment.
DFD-29 exhibited superiority over both placebo treatment and 40 mg Oracea (doxycycline) tablets.
Over the 16-week trial durations, no significant safety signals were reported.
If approved by the FDA, DFD-29 has the potential to become the only oral, systemic therapy approved to address both erythema and inflammatory lesions associated with rosacea, as well as a best-in-class therapeutic option for this indication.
“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," said Claude Maraoui, co-founder, president, and chief executive officer of Journey Medical, in a press release. "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."
Journey Medical Corporation. Journey Medical Corporation submits New Drug Application to FDA for DFD-29 to treat rosacea. GlobeNewswire News Room. January 5, 2024. Accessed January 5, 2024. https://www.globenewswire.com/news-release/2024/01/05/2804636/0/en/Journey-Medical-Corporation-Submits-New-Drug-Application-to-FDA-for-DFD-29-to-Treat-Rosacea.html