Pipeline

Clinical Pipeline > FMX103*

1.5% Minocycline foam being investigated for the treatment
of moderate-to-severe papulopustular rosacea in adults

Rosacea: An increasingly widespread skin disorder with significant burdens to patients 1

Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin, and forehead. It can create psychosocial burdens, such as embarrassment, anxiety, and low self-esteem that can 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, and accounts for approximately 5 million4 prescriptions per year.

FMX103

Treatments: Limited treatment options
present opportunity for new product entry

Mild papulopustular rosacea is often treated by topical antimicrobials (metronidazole, clindamycin, and ivermectin), azelaic acid, vasoconstrictors, or retinoids, while the mainstay for the treatment of moderate-to-severe rosacea are oral antibiotics such as doxycycline and, less frequently, tetracycline and off-label use of oral minocycline.5

FMX103: Late-stage development of a
topical minocycline

FMX103 is Foamix’s investigational proprietary 1.5% minocycline foam formulation being developed for moderate-to-severe papulopustular rosacea in adults. If approved, FMX103 is targeted to be the first FDA-approved topical minocycline treatment for moderate-to-severe papulopustular rosacea.

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) anticipated Q2 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.
  5. Moustafa FA, et al. Drugs. 2014; 74:1457-1465.