Journey Medical Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) 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.
Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, "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. 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."
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. Srinivas Sidgiddi, M.D., Vice President, Research & Development at Journey Medical, noted that DFD-29 demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea 40 mg capsules, and placebo for Investigator’s Global Assessment (IGA) treatment success as well as the reduction in the total inflammatory lesion count in both studies. For the secondary endpoint evaluating erythema (redness) associated with rosacea, DFD-29 showed a statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials.
Phase 3 Trial Results
In the MVOR-1 trial (NCT05296629), 65.0% of patients in the DFD-29 group demonstrated IGA success, compared to 46.1% in the doxycycline group (P=0.007) and 31.2% in the placebo group (P<0.001). The DFD-29 group also showed a mean reduction of 21.3 lesions, while the doxycycline group showed a mean reduction of 15.9 lesions and the placebo group showed a mean reduction of 12.2 lesions from baseline to week 16 (P<0.001 for both comparisons with DFD-29).
In the MVOR-2 trial (NCT05343455), 60.1% of patients in the DFD-29 group demonstrated IGA success, compared to 31.4% in the doxycycline group (P<0.001) and 26.8% in the placebo group (P<0.001). The DFD-29 group showed a mean reduction of 18.4 lesions, the doxycycline group showed a mean reduction of 14.9 lesions, and the placebo group showed a mean reduction of 11.1 lesions from baseline to week 16 (P<0.001 for both comparisons with DFD-29).
About Rosacea
Rosacea is a chronic inflammatory skin condition affecting approximately 16 million people in the United States, characterized by facial redness, small red pus-filled bumps, and visible blood vessels.
Emrosi Approval
On November 1, 2024, the FDA approved DFD-29, now branded as Emrosi (minocycline hydrochloride) extended-release capsules, 40 mg, for the treatment of inflammatory lesions of rosacea in adults. Emrosi contains 40 mg of minocycline (equivalent to 43.19 mg of minocycline hydrochloride) as 10 mg immediate-release and 30 mg extended-release beads and is administered orally, once daily.
