New data from LEO Pharma A/S shows aerosol foam Enstilar, the company’s dual-action investigational aerosol foam for the treatment of psoriasis vulgaris, provided rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis. The data is from a PSO-FAST Phase 3 clinical trial.
Between 70 percent and 90 percent of people with psoriasis experience itching, which can cause patients stress or embarrassment. Psoriasis patients suffering from itching also may sweat, feel a sensation of heat or pain in the affected area, have difficulty falling asleep or are awakened during the night due to itching.
“These data are encouraging for the vast majority of psoriasis patients that are also suffering from itch related to their disease,” said Dr. Craig Leonardi, a Clinical Professor of Dermatology at St. Louis University School of Medicine in the U.S. and the lead investigator of the PSO-FAST clinical trial. “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.”
Additional data from the PSO-FAST clinical trial showed that 81 percent of patients receiving Enstilar® experienced clinically meaningful improvements in health-related quality of life (HRQoL). The HRQoL of patients was assessed using the Dermatology Life-Quality Index (DLQI) and the generic five-dimension EQ5D questionnaire. Patient feedback on HRQoL was assessed with DLQI at baseline and weeks one, two and four and EQ5D was assessed at baseline and week four, noted BioSpace.com.
“We are pleased with the results of the PSO-FAST trial and believe these data further highlight the value Enstilar® may provide to patients living with psoriasis,” said Kim Kjøller, senior vice president, global development at LEO Pharma.
In December 2014, according to BioSpace.com, LEO Pharma submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Enstilar® and Marketing Authorization Applications were submitted to 30 Regulatory Agencies in Europe in March 2015.