Atopic dermatitis or AD is a chronic, pruritic inflammatory skin disease that affects both children and adults. AD typically presents with inflamed skin lesions and significant pruritus, and is characterized by skin barrier disruption and immune dysregulation. Pruritus is often the primary complaint associated with this disease.
According to the National Eczema Association, 17.8 million people in the United States have AD. There are an estimated 8 million adults who suffer from AD1, and AD affects approximately eleven percent of children in the United States2 and up to twenty percent of children worldwide.3 Most physicians surveyed in a recent study conducted for Menlo Therapeutics indicated that many of their atopic dermatitis patients remain significantly itchy despite use of moisturizers, topical anti-inflammatory agents, antihistamines, or other therapies.
Menlo Therapeutics is conducting a phase 2 trial (NCT02975206) evaluating the safety and effectiveness of serlopitant for pruritus associated with atopic dermatitis. More than forty clinical sites in the US are enrolling approximately 450 subjects in a randomized, double-blind, placebo-controlled, study named ATOMIK. Eligible subjects include adolescents and adults aged 13 years or older with a history of atopic dermatitis who have severe pruritus despite treatment with standard of care atopic dermatitis therapies. Results of this study are expected in 2018.