- FMX103 1.5%, a minocycline 1.5% foam, is efficacious and shows good safety for patients with moderate to severe papulopustular rosacea, according to results from 2 phase 3 trials (FX2016-11 and FX2016-12).
Why this matters
- Effective topical treatment options are lacking for patients with rosacea.
- FMX103 1.5% was associated with a greater reduction in inflammatory lesion number compared with vehicle control:
- −17.57 vs −15.65 (P=.0031) in the FX2016-11 trial.
- −18.54 vs −14.88 (P<.0001 the fx2016-12 trial.>
- FMX103 1.5% was associated with higher rates of Investigator Global Assessment treatment success compared with vehicle control:
- 52.1% vs 43.0% (P=.0273) in FX2016-11.
- 49.1% vs 39.0% (P=.0077) in FX2016-12.
- No serious treatment-related treatment-emergent adverse events (TEAEs) were reported.
- The most common noncutaneous TEAEs were viral upper respiratory tract infection, upper respiratory tract infection, and headache.
- FMX2016-11 included 751 patients with rosacea: 495 who received FMX103 1.5%, and 256 who received vehicle foam.
- FMX2016-12 included 771 patients with rosacea: 514 who received FMX103 1.5%, and 257 who received vehicle foam.
- Funding: Foamix Pharmaceuticals Inc.
- Selected clinical trial population may not reflect real-world scenarios.