The Food and Drug Administration has granted Fast Track status to Axovant Sciences for their investigational New Drug application for intepirdine for the treatment for dementia with Lewy bodies.

The HEADWAY-DLB study will evaluate the safety, efficacy and tolerability of intepirdine over 24 weeks of treatment at oral-doses of 70mg and 35mg daily. HEADWAY-DLB is a Phase 2b international, multi-center, double-blind, placebo-controlled clinical study involving 240 patients with dementia with Lewy bodies; patients currently receiving stable background therapy for dementia with Lewy bodies are permitted to participate. 

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Intepirdine is an orally-administered, potent antagonist of the 5HT6 receptor, that when used together with a cholinesterase inhibitor, can increase the concentration of acetylcholine through complementary mechanisms.

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