Acadia Pharmaceuticals announced this week that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for its drug Nuplazid (the compound pimavanserin) for the treatment of psychosis associated with Parkinson’s disease (PD).
PD psychosis can include hallucinations (seeing things that aren’t there) and delusions (false and generally paranoid beliefs). The causes are a complex interplay of disease (often emerging later in the course of PD) and medication effect. The use of dopaminergic medication has been associated with PD psychosis, as have older age, sleep disturbance, cognitive impairment, dementia and depression.
Right now doctors may prescribe anti-schizophrenic drugs to treat PD psychosis, but there are serious side effects and safety concerns with those therapies.
Acadia’s Nuplazid offers a new option. A Phase III study showed the drug significantly reduced psychosis compared to placebo without worsening motor function. The study also showed the drug was safe and well tolerated.
A New Drug Application is one of the last steps in a drug’s journey to pharmacy shelves. This is the formal step a drug sponsor takes to ask that that FDA consider approving a drug for market. The FDA then has 60 days to decide whether to review the application (they can refuse if, for example, the application is incomplete).
Given the suboptimal treatment options for PD psychosis, Acadia requested priority review of its New Drug Application, which would accelerate the review deadline from 10 months to six months.
Read more about a drug’s journey through testing and the US FDA review
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