DFD-29 on it’s way, now has an NDA

Written by on January 10, 2024 in Minocycline, New Rosacea Treatments, tetracyclines with 0 Comments

Journey Medical’s modified released 40mg minocycline (still code named DFD-29) has published positive Phase 3 Clinical Trial data and is now sitting waiting on a New Drug Application. The company press release touts the combination treatment for both the inflammatory lesions and the redness of rosacea. By comparison, Oracea, the competing product that DFD-29 claims to out-perform, is not indicated for the redness off rosacea, only for the treatment of the papules and pustules of rosacea.

The press release contains the somewhat hopeful claim that “DFD-29 could fundamentally improve the treatment paradigm for patients suffering from both inflammatory lesions and erythema (redness) from rosacea”.

There is a still long way to go before rosacea sufferers get to see whether this new form of a tetracycline will offer a significant benefit over Oracea. It is encouraging, though, that this in-development product has made it to NDA stage.

DFD-29 NDA Press Release

Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea

SCOTTSDALE, Ariz., Jan. 05, 2024 (GLOBE NEWSWIRE) —  Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the Company has submitted a New Drug Application (“NDA”) to the 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.

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

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