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Vanda Reports results from the EPIONE study of Tradipitant in the treatment of Pruritus in Atopic Dermatitis
- Tradipitant antipruritic effects not seen in moderate or severe Atopic Dermatitis and the study did not meet its primary endpoint - Tradipitant
About this update from Vanda Pharmaceuticals Inc.
[{"type":"text","content":"- Tradipitant antipruritic effects not seen in moderate or severe Atopic Dermatitis and the study did not meet its primary endpoint\n - Tradipitant significantly improved severe itch and nighttime sleep in patients with mild Atopic Dermatitis\n - Pruritus improved in over 70% of patients with mild Atopic Dermatitis and seen after the first day of treatment\n\n\nWASHINGTON, Feb. 25, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA) today announced results from a Phase III clinical trial (EPIONE) of tradipitant for the treatment of pruritus in atopic dermatitis (AD) in adults. The EPIONE study did not meet its primary endpoint in reduction of pruritus across the overall study population. However, the antipruritic effect of tradipitant was robust in the mild AD study population. Mild AD represents over 60% of the total AD population in the U.S.1, 2 The EPIONE study continued to demonstrate that tradipitant is safe and well-tolerated.\n\"Although we are disappointed that EPIONE did not meet its primary endpoint, the profile of efficacy demonstrated in this study potentially addresses a highly unmet need of treating intractable pruritus for a large portion of AD patients,\" said Mihael H. Polymeropoulos, M.D., Chief Executive Officer of Vanda. \"Due to their potent immuno-suppressive effects, current systemic therapies for AD are typically only used in moderate to severe AD. The safe profile of tradipitant, coupled with a significant and immediate onset of itch reduction by the first full day of treatment, may provide a much-needed therapy for the majority of AD patients that experience mild AD lesion severity but still suffer from significant pruritus.\"\nEPIONE was a randomized, placebo-controlled Phase III study (n=341) in AD patients with severe pruritus with a range of disease severity presentation from mild (23%) to moderate (64%) and severe (13%) as determined by the Investigator's Global Assessment scale (IGA). Patients were randomized 1:1 to receive either tradipitant or placebo for a treatment period of 8 weeks. Patients were assessed at baseline and post-randomization with a number of symptomatic and disease severity scales at regular intervals. \nThe EPIONE study examined the hypothesis that tradipitant dosed at 85 mg twice a day offers improvement of the disease symptoms and signs of AD over the evalu...