Emrosi FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 5, 2024.
FDA Approved: Yes (First approved November 1, 2024)
Brand name: Emrosi
Generic name: minocycline hydrochloride
Dosage form: Extended-Release Capsules
Previous Name: DFD-29
Company: Journey Medical Corporation
Treatment for: Rosacea
Emrosi (minocycline hydrochloride) is a low-dose, modified-release capsule formulation of the approved tetracycline-class drug minocycline indicated to treat the inflammatory lesions of rosacea in adults.
- Emrosi has not been evaluated in the treatment or prevention of infections. To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, Emrosi must be used only as indicated.
- Rosacea is a long-term, inflammatory skin condition characterized by facial redness and inflammatory lesions (papules and pustules) and telangiectasia (spider veins).
- Minocycline is a well established tetracycline antibiotic first approved over fifty years ago for the treatment of a wide range of bacterial infections. Lower, sub-antimicrobial doses of tetracyclines (including minocycline) have demonstrated anti-inflammatory properties, and also prevent selection pressure for bacterial resistance.
- Each Emrosi capsule contains 40 mg of minocycline (equivalent to 43.19 mg of minocycline hydrochloride) as 10 mg immediate-release and 30 mg extended-release beads.
- FDA approval of Emrosi was supported by positive data from two Phase 3 clinical trials (MVOR-1 and MVOR-2) for the treatment of rosacea. The trials met all co-primary and secondary endpoints, and Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment (Oracea® 40 mg capsules) and placebo for Investigator’s Global Assessment treatment success as well as the reduction in total inflammatory lesion count in both studies.
- Emrosi capsules are administered orally, once daily.
- Warnings and precautions associated with Emrosi include serious skin/hypersensitivity reactions; permanent discoloration of the teeth and reversible inhibition of bone growth if used during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years; Clostridioides difficile-associated diarrhea; hepatotoxicity; central nervous system side effects including light-headedness, dizziness, or vertigo; idiopathic intracranial hypertension; autoimmune syndromes; and metabolic effects.
- The most common adverse reaction (incidence ≥1%) is dyspepsia.
Development timeline for Emrosi
Further information
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