8. Nuplazid

an old man without a smile

Active Ingredient: pimavanserin
Disease: Parkinson’s disease
Peak sales estimate: $1 billion by 2021
Approved: April 29
Company: Acadia

The scoop: After two delays by the company in submitting its NDA, Acadia Pharmaceuticals snagged an approval for Nuplazid, its FDA-designated “breakthrough” antipsychotic to prevent hallucinations and delusions in Parkinson’s patients. Its novel mechanism targets 5-HT2A receptors, which should keep it from interfering with treatments that spur production of dopamine to treat motor symptoms. That won support among a large majority of FDA advisers despite the fact that FDA staff flagged serious concerns about the risks. It was given a black-box warning on the drug noting a significant increase in the risk of death among patients taking the drug. There is a significant patient pool for the drug, given there are a million Parkinson's patients in the U.S., and 50,000 new cases diagnosed every year. Between 40% and 50% of those patients will suffer from hallucinations and delusions. Acadia also is studying the the antipsychotic for Alzheimer’s, which could significantly increase its potential to earn blockbuster revenue. —Eric Palmer

8. Nuplazid

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