Pipeline

Clinical Pipeline > FMX101*

4% Minocycline foam being investigated 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 patients making more than 14 million physician visits per year and over 18 million total prescriptions.2,3 With the significant epidemiological impact of acne, there is a clear need for new advances in the acne treatment space.

FMX101

Antibiotics: Designing the first minocycline topical option

Antibiotics have long been considered a mainstay in acne management. The most recent American Academy of Dermatology (AAD) Treatment Guidelines recommend antibiotics first-line in acne treatment regimens for mild, moderate, and severe acne.Tetracycline-class antibiotics, including minocycline, are the most commonly prescribed antibiotics to treat acne; however, they are only available in oral dosage forms.3

FMX101: Late-stage development of a topical minocycline

FMX101 is Foamix's investigational proprietary 4% minocycline foam formulation being developed for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older. If approved, FMX101 is targeted to be the first FDA-approved topical minocycline treatment for moderate-to-severe acne.

Development timeline includes:

  • Third phase 3 study complete
  • Top-line results released for first two phase 3 pivotal studies
  • Open-label safety extension completed
  • NDA submitted December 2018
  • Prescription Drug User Fee Act (PDUFA) Target Action Date of
    October 20, 2019

 

*The safety and efficacy of FMX101 has not been established and there is no guarantee that it will receive health authority approval or become commercially available.
 
References:
  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 July 1, 2019.
  4. Zaenglein AL, et al. J Am Acad Dermatol. 2016;64:945-973.e33.