Arcutis Reports the NDA Submission of Roflumilast to the US FDA for the Treatment of Seborrheic Dermatitis
Shots:
- The submission was based on the P-III trial (STRATUM) evaluating roflumilast (0.3%) vs vehicle in adults & adolescents
- The trial met its 1EPs i.e., 79.5% vs 58.0% of patients treated with roflumilast foam achieved IGA success @8wk., & significant improvement from vehicle on IGA success @2wk. 51.3% reached clear @8wk., was well-tolerated with a favorable safety & tolerability profile
- The study showed significant improvements on all 2EPs incl. itch, scaling & erythema, ≥60% achieved an itch response @8wk. (62.8% vs 40.6%) with significant improvements @2 & 4wk., incidence of TEAEs was low & similar b/w treatment arms, no treatment-related SAEs were reported, ~90% completed the full 8wks. with few treatment discontinuations due to AEs (0.7% vs 2.0%)
Ref: Arcutis | Image: Arcutis
Related Post:- Arcutis Reports P-II Study Results of Roflumilast for the Treatment of Chronic Plaque Psoriasis
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