DFD-29 set to be approved on Nov 4 2024

News today that Journey Medical Corporation is looking forward to having their Oracea competitor, still known as DFD-29, approved by the FDA before the end of the year. Having accepted the New Drug Application, the FDA is now in the final stages of approving this new 40mg minocycline that is showing promise as a treatment for the both the inflammatory lesions and erythema associated with rosacea.

Journey Medical highlight their clinical trial results showing a superior success in treating the papules and pustules of rosacea compared to Oracea, and a statistically measurable improvement in the redness of rosacea. This improvement in symptoms of the lumps and bumps of rosacea as well as the red face of rosacea is yet to be seen in large scale usage once it becomes widely available.

DFD-29 shows similar adverse outcomes when compared to Oracea.

Press Release

Journey Medical (DERM) Up as FDA Accepts Skin Disease Drug NDA

Journey Medical Corporation’s DERM shares rose 10% on Mar 18, after the company announced that its new drug application (NDA) for its key pipeline candidate, DFD-29 capsules (40mg), to treat inflammatory lesions and erythema of rosacea in adults, has been accepted by the FDA for review.

A decision from the regulatory body is expected on Nov 4, 2024.

DFD-29’s significant impact on erythema reduction could prove to be the differentiating factor over the current standard of care for rosacea. Journey Medical believes DFD-29 can potentially change the treatment paradigm for rosacea.

Management believes that DFD-29, if approved, will become the only oral medication to address both inflammatory lesions and erythema from rosacea.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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