Clinical Pipeline > FMX101*
4% Minocycline foam being investigated for the treatment of moderate-to-severe acne
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.4 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
- (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.
- Mancini AJ. Adv Stud Med. 2008;8:100-105.
- Symphony Health Services PHAST. Accessed July 1, 2019.
- Zaenglein AL, et al. J Am Acad Dermatol. 2016;64:945-973.e33.