Investigational Aerosol Foam Brings Rapid Itch Relief for Patients with Plaque

Aerosol foam calcipotriol/betamethasone diproprionate (Enstilar/LEO Pharma) has been shown to successfully and rapidly relieve itchiness and improve itch-related sleep loss in patients suffering from psoriasis vulgaris (plaque psoriasis).

Data showing favorable results from the “Psoriasis vulgaris, a Four-week, vehicle-controlled, efficacy And Safety Trial (PSO-FAST) were presented at the 23^rd World Congress of Dermatology in Vancouver.

The 426 psoriasis patients involved in the study were split into two groups — 323 individuals received treatment with Enstilar and 103 were given placebo.

The researchers noticed significant improvements in itch by the 4-week mark within 80% of the Enstilar group. Patients treated with Enstilar also experienced improvements in itch-related sleep loss as well; 36% of individuals found clear improvement as soon as three days after starting treatment, and 71% experienced improvements by week 4.

Additionally, patients’ health-related quality of life was assessed using the Dermatology Life-Quality Index (DLQI) and the EQ5D questionnaire. The researchers reported that 81% of the Enstilar treatment group experienced “clinically meaningful” improvements in health-related quality of life.

Craig Leonardi, MD, Clinical Professor of Dermatology, St. Louis University School of Medicine, St. Louis, MO, commented, “These data are encouraging for the vast majority of psoriasis patients that are also suffering from itch related to their disease. Itch can have a significant impact on the overall quality of life for psoriasis patients and having a well tolerated and effective treatment option to rapidly relieve itch is important. “

LEO Pharma submitted a New Drug Application (NDA) to the Food and Drug Administration for Enstilar in December and submitted a Marketing Authorization Application to 30 Regulatory Agencies in Europe in March 2015.