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A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks

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Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Mar 2024

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At a glance

  • Drugs Minocycline (Primary) ; Doxycycline hyclate
  • Indications Rosacea
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MVOR-1
  • Sponsors Journey Medical Corporation
  • Most Recent Events

    • 18 Mar 2024 According to a Journey Medical Corporation media release, FDA has accepted the Company's New Drug Application ("NDA") for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. The FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of November 4, 2024
    • 05 Jan 2024 According to a Journey Medical Corporation media release, based on positive data from Journey Medical's two DFD-29 Phase 3 clinical trials, 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.
    • 02 Jan 2024 According to a Journey Medical Corporation media release,company a has entered into a credit facility with an affiliate of SWK Holdings Corporation a specialized finance company with a focus on the global healthcare sector, providing for borrowings of up to $20 million and this The funding will support general corporate purposes, as well as anticipated expenses for DFD-29, including an upcoming New Drug Application submission pending FDA approval.
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