Prurigo nodularis (PN) is a chronic skin disorder affecting primarily older adults and is characterized by multiple, firm, itchy nodules which may be found on a patient’s arms, legs torso or back. PN is often quite difficult to treat adequately and there are no currently approved therapies in the U.S. indicated for treatment of PN. A vicious cycle of repeated itching, scratching, and sometimes picking leads to inflamed often hard and crusty skin nodules that are persistently itchy.1 The itching sensation in PN is extreme in many patients. In some patients, the itching may cause scratching or picking to the point of bleeding or pain.
No therapies are approved for the treatment of PN. Serlopitant therapy is being developed to help manage pruritus associated with prurigo nodularis.
Menlo Therapeutics completed phase 2 trial, TCP-102, evaluated serlopitant for the treatment of pruritus associated with prurigo nodularis (NCT02196324). The 127-subject, multi-center, randomized, placebo-controlled, trial compared once-daily, orally administered 5 mg tablets of serlopitant vs. placebo for 8 weeks. This study was conducted at 15 clinical sites in Germany. TCP-102 met its primary efficacy endpoint and key secondary endpoints, demonstrating a statistically significant reduction in pruritus (p<0.001 for the primary efficacy analysis at week 8) in subjects treated with serlopitant compared with placebo. Statistically significant reduction in pruritus was seen for the treatment group vs. placebo group at all measurement time points (2, 4 and 8 weeks). Treatment with serlopitant was well tolerated in the study. Results of this trial were presented at the 2017 American Academy of Dermatology annual meeting in Orlando, Florida.
Menlo Therapeutics is planning to initiate two phase 3 studies intended to evaluate the efficacy and safety of serlopitant as a treatment for pruritus associated with prurigo nodularis.