DFD-29 FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 15, 2024.
FDA Approved: No
Brand name: DFD-29
Generic name: minocycline hydrochloride
Company: Journey Medical Corporation
Treatment for: Rosacea
DFD-29 (minocycline hydrochloride) is a low-dose, modified-release capsule formulation of minocycline in development for the treatment of inflammatory lesions and erythema of rosacea in adults.
- Rosacea is a long-term, inflammatory skin condition characterized by facial redness and inflammatory lesions (pimples and bumps).
- DFD-29 is a low-dose formulation of minocycline, a member of the well-established class of tetracycline antibiotics. Lower, sub-antimicrobial doses of tetracyclines (including minocycline and doxycycline) have demonstrated anti-inflammatory properties and also prevent selection pressure for bacterial resistance.
- The New Drug Application submission for DFD-29 is supported by positive data from Journey Medical’s two Phase 3 clinical trials (MVOR-1 and MVOR-2) for the treatment of rosacea. DFD-29 demonstrated statistical superiority over both the current standard-of-care treatment (Oracea® (doxycycline USP) 40 mg capsules) and placebo for Investigator’s Global Assessment treatment success as well as the reduction in the total inflammatory lesion count in both studies. On a secondary endpoint related to erythema assessment, DFD-29 showed statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials.
Development timeline for DFD-29
Further information
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