Clinical Pipeline > FCD105*
3% minocycline, 0.3% adapalene combination foam formulation being investigated for the treatment of moderate-to-severe acne vulgaris in patients 12 years of age and older.
Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and other areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate-to-severe disease that may impact self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.
Mid-stage development of a topical minocycline, adapalene fixed-dose combination
FCD105 is Foamix’s proprietary 3% minocycline, 0.3% adapalene combination foam formulation under investigation for the treatment of moderate-to-severe acne vulgaris. FCD105 combines the bacteriostatic and anti-inflammatory properties of minocycline with the third-generation retinoid, adapalene, which acts in regulating the differentiation of follicular epithelial cells. Oral minocycline and topical adapalene products are approved for use in the treatment of acne vulgaris in the United States, with the latter available in combination and as monotherapy. Pending a successful development program, the FCD105 NDA is intended to be filed under a 505(b)(2) regulatory pathway.
Development milestones include:
- 3 week and 3 month dermal toxicity complete
- Positive Phase 2 study topline results reported Q2 2020
- Phase 3 program start 1H 2021
*The safety and efficacy of FCD105 has not been established and there is no guarantee that it will receive health authority approval or become commercially available.
- Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E et al. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. Journal of the American Academy of Dermatology 2006;55:490-500.