Clinical Pipeline > FMX101*


Clinical Pipeline > FMX101*

Minocycline foam, 4% for the treatment of Moderate-to-Severe Acne

Acne: Large Market Potential to Address Unmet Patient Needs

Acne is a highly prevalent skin condition. In the US, approximately 50 million people of all ages and races have acne, with moderate-to-severe acne affecting approximately 10 million.1 Acne treatment in the US accounts for more than 14 million physician visits per year and over 5 million branded prescriptions.2;3 Despite the significant epidemiological impact of acne, there have been no new molecular entities launched since the mid-90s (adapalene, 1996).

Antibiotics: Designing a 1st In-class Topical Option

Antibiotics have long been considered a mainstay in acne management. The most recent AAD Treatment Guidelines recommend antibiotics 1st line in acne treatment regimens for mild, moderate, and severe acne.4 Minocycline (Solodyn®) is the most commonly prescribed branded antibiotic for acne treatment; however, it is only available as an oral dosage form.3

FMX101: Late Stage Development of a Topical Minocycline

FMX101 is Foamix's investigational proprietary 4% minocycline foam formulation indicated for the treatment of moderate-to-severe acne. If approved, FMX101 is targeted to be the first FDA-approved topical minocycline treatment for moderate-to-severe acne.

  • Third Phase 3 study complete
  • Top-line results released for first two Phase 3 pivotal studies
  • Open-label safety extension completed
  1. (1) AAD. Acne Stats and Facts. www.aad.org/media-resources/stats-and-facts/conditions. Accessed March 30, 2016. (2) GlobalData, EpiCast. Acne Vulgaris Epidemiology Forecast to 2022;33-34.
  2. Mancini AJ. Adv Stud Med. 2008;8:100-105.
  3. Symphony Health Services PHAST (accessed 1.18.17). Market shares of the oral branded prescription acne drug market and the topical branded prescription acne drug market according to the total number of prescriptions.
  4. Zaenglein AL, et al. J Am Acad Dermatol. 2016;64:945-973.e33.

*Investigational use only – not available for commercial distribution