Menlo Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for serlopitant for the treatment of pruritus associated with prurigo nodularis (PN). Breakthrough Therapy designation is granted to expedite the development and review process for drugs intended to treat a serious condition where preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over available therapies on a clinically significant endpoint. Menlo’s request for this designation was supported primarily by positive results from a Phase 2 clinical trial conducted in 127 patients with prurigo nodularis in which serlopitant met its primary and multiple secondary efficacy endpoints. At week eight, for the primary efficacy analysis, the serlopitant 5 mg group showed a 36 mm improvement from baseline in average itch compared with a 19 mm improvement for the placebo group (p = 0.001). Menlo is currently enrolling patients in two Phase 3 clinical trials (one in the U.S. and one in Europe) to evaluate serlopitant as a treatment for pruritus associated with prurigo nodularis. Data from each trial is expected by the first quarter of 2020.