Journey Medical Submits NDA For DFD-29 To FDA For Treatment Of Rosacea In Adults
(RTTNews) - Pharmaceutical company Journey Medical Corp. (DERM) announced Friday that the Company has submitted a New Drug Application or NDA, to the U.S. Food and Drug Administration or 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. If approved, DFD-29 has potential to be best-in-class and the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea
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.
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