Clinical Pipeline > FMX103*


Clinical Pipeline > FMX103*

Minocycline foam, 1.5% for the treatment of Moderate-to-Severe Papulopustular Rosacea

Rosacea: An Increasingly Widespread Skin Disorder with Significant Burdens to Patients1

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. Rosacea is most frequently seen in adults between 30 and 60 years of age. It affects more than 16 million1 people in the United States, and accounts for approximately 5 million2 prescriptions per year.

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 or retinoids, while the mainstay for the treatment of moderate-to-severe rosacea are oral antibiotics such as minocycline and doxycycline.3

FMX103: Late Stage Development of a Topical Minocycline

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

  • Top-line results released for first two Phase 3 pivotal studies
  • Phase 2 results released and peer-reviewed

 

  1. (1) National Rosacea Society. Rosacea Review; Winter 2010. http://www.rosacea.org/rr/2010/winter/article_1.php. Accessed May 16, 2016; (2) Wilkin J, et al. J Am Acad Dermatol. 2002;46:584-587.
  2. Symphony Health Services PHAST: 2016 Market Data (accessed 1.24.17), weighted values, rosacea usage. Select brands, unweighted values (>75% rosacea usage).
  3. Drugs (2014) 74:1457-1465.

*Investigational use only – not available for commercial distribution