The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational drug nelotanserin (Axovant Sciences) for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB).

Nelotanserin is a novel once-daily oral 5HT2A inverse agonist. The 5HT2A receptor has been associated with neuropsychiatric effects, including visual hallucinations. 

Nelotanserin is currently being investigated in 2 separate double-blind, randomized, placebo-controlled Phase 2 trials. One study (n=20) is evaluating nelotanserin 40mg and 80mg over a 4-week treatment period in patients with DLB who experience frequent hallucinations. The second study (n=60) is evaluating the safety, efficacy, and tolerability of nelotanserin 80mg in patients with DLB who have rapid eye movement (REM) sleep behavior disorder. 

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A study by the Lewy Body Dementia Association (LBDA) estimated that 1.3 million Americans are affected by the condition, however, it is widely accepted that the condition is underdiagnosed. DLB is the second most common form of progressive dementia.

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