SCOTTSDALE, Ariz. - Journey Medical Corporation (NASDAQ:DERM), a commercial-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for DFD-29, a treatment for rosacea. The FDA has set a goal date of November 4, 2024, to make a decision under the Prescription Drug User Fee Act (PDUFA).
Claude Maraoui, President and CEO of Journey Medical, expressed confidence in the potential of DFD-29 to become a unique treatment option for rosacea, targeting both inflammatory lesions and erythema. The company believes that, if approved, DFD-29 will be the only oral medication to address these specific symptoms of rosacea.
The NDA submission was supported by positive results from two Phase 3 clinical trials, which demonstrated DFD-29's statistical superiority over the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo. The trials met all co-primary and secondary endpoints, with subjects completing the 16-week treatment without significant safety issues.
Rosacea is a chronic inflammatory skin condition affecting an estimated 16 million people in the United States. It is characterized by redness, visible blood vessels, and small red, pus-filled bumps on the face.
Journey Medical, headquartered in Scottsdale, Arizona, specializes in marketing FDA-approved prescription pharmaceutical products for dermatological conditions. The company is an affiliate of Fortress Biotech, Inc. (NASDAQ:FBIO) and markets a portfolio of branded and generic skin care products.
The acceptance of the NDA for DFD-29 marks a significant milestone for Journey Medical in its quest to offer new treatment options for skin conditions. The company's commitment to addressing unmet medical needs in dermatology is reflected in its product development programs.
This news is based on a press release statement from Journey Medical Corporation.
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