15 January 2019 - Menlo Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for serlopitant for the treatment of pruritus associated with prurigo nodularis.

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 (measured by the itch visual analog scale) 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.

Read Menlo Therapeutics press release