Once-Daily Topical Cream for Rosacea Approved
The exact mechanism of ivermectin is unknown. However, it is reported to have anti-inflammatory and antiparasitic activity.
The FDA approval was supported by two Phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled parallel-group studies. Soolantra Cream achieved each of its co-primary efficacy endpoints and treatment effect was seen as early as Week 2 with continuous improvement. Data from the long-term extension studies showed that Soolantra Cream was also safe and well-tolerated for another 40 weeks (up to 52 weeks total). In a separate head-to-head study vs. metronidazole 0.75% cream, treatment with Soolantra Cream was more effective from as early as Week 3 onward.
Soolantra Cream will be available as a 1% strength in 30g tubes.
For more information call (866) 735-4137 or visit GaldermaUSA.com.