FMX103

Clinical Pipeline > FMX103*

1.5% Minocycline foam being investigated for the treatment of inflammatory lesions of rosacea in adults

Rosacea: An increasingly widespread skin disorder with potential burdens to patients1

Rosacea: An increasingly widespread skin disorder with potential burdens to patients1

Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules). It may create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that may adversely affect quality of life.2 Rosacea is most frequently seen in adults between 30 and 60 years of age.3 It affects more than 16 million1 people in the United States; up to 28% of these sufferers have rosacea with inflammatory lesions, and accounts for approximately 5 million4 prescriptions per year.

Treatments: Limited treatment options present opportunity for new product entry

FMX103:

Late-stage development of a topical minocycline

FMX103 is VYNE Therapeutics’s investigational proprietary 1.5% minocycline foam formulation being developed for inflammatory lesions of rosacea in adults. If approved, FMX103 is targeted to be the first FDA-approved minocycline treatment for rosacea ever.

Development milestones include:

  • Top-line results released for first two phase 3 pivotal studies
  • Phase 2 results released and peer-reviewed
  • Open-label safety extension completed
  • NDA submitted August 2, 2019
  • Prescription Drug User Fee Act (PDUFA) date of June 2, 2020

*The safety and efficacy of FMX103 has not been established and there is no guarantee that it will receive health authority approval or become commercially available.

References:

  1. Two, et al. Rosacea. J Am Acad Dermatol. 2015 May;72(5):749-58
  2. Oussedik E, Bourcier M, Tan J. Dermatol Clin. 2018 Apr; 36(2):103-113. Epub 2017 Nov 29.
  3. Rosacea. National Institute of Arthritis and Musculoskeletal and Skin Diseases. https://www.niams.nih.gov/health-topics/rosacea#tab-risk.
  4. Symphony Health Services PHAST: 2016 Market Data, weighted values, rosacea usage. Select brands, unweighted values (>75% rosacea usage). Accessed January 24, 2017.