Vanda reports mixed Phase II data from atopic dermatitis trial of tradipitant

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) reported data from the double-blind, U.S. Phase II Study 2102 in 168 chronic pruritus patients with mild to severe atopic dermatitis showing that twice-daily 85 mg oral tradipitant for 8 weeks missed the primary endpoint of improving mean itch visual analog scale (VAS) score vs. placebo (reductions of 41.5 vs. 35.8 points, p=0.306). Tradipitant did meet the secondary endpoints of improving worst itch VAS score (reductions of 44.2 vs. 30.6 points, p=0.019), total Scoring Atopic Dermatitis Index (SCORAD) scale score (reductions of 21.3 vs. 13.6 points, p=0.008), Clinical Global Impression of Change (CGI-C) (2.6 vs. 3.3 points, p=0.007) and quality of life (QOL) as measured by the Patient Benefit Index (PBI) (p=0.038) vs. placebo.

Vanda said it plans to meet with FDA "in the near future to further define and confirm the clinical development path towards registration" of tradipitant for atopic dermatitis...