Acadia’s Nuplazid (pimavanserin) has performed so well in Phase III clinical trial that the trial has been halted early.

Nuplazid is being investigated for the treatment of delusions and hallucinations associated with dementia-related psychosis (DRP). Interim results from the trial showed that Nuplazid demonstrated a significantly longer time to relapse of psychosis compared to placebo. Considering the high statistical standards that are set in order to stop a trial before its planned completion based on positive results, this demonstrates Nuplazid’s strong efficacy for DRP and should help the drug receive approval.

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This was some much needed good news for Acadia, after Nuplazid’s failure in a Phase III trial evaluating it as an add-on therapy to antipsychotic treatment for schizophrenia in July. Acadia also faced issues in 2018, when the US Food and Drug Administration (FDA) investigated the safety of Nuplazid, the only approved treatment for Parkinson’s disease psychosis, after hundreds of patients died while taking the drug. However, this has now been resolved, as the FDA decided that the risks were consistent with the black-box warning on the drug label.

Acadia has announced that it plans to file with the FDA to expand Nuplazid’s indications to DRP in 2020. If it is approved, it would become the first treatment for DRP. While dementia can greatly lower a patient’s quality of life, psychosis dramatically adds to the burden of the disease, particularly for caregivers, indicating that there is a great unmet need for treatment.

As such, the FDA granted breakthrough therapy designation to Nuplazid for the treatment of DRP in 2017. This should help with the speed of Nuplazid’s approval.

By 2025, GlobalData forecasts total annual revenue of $1.5 billion for Nuplazid.

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