SEC filings by Acadia Pharmaceuticals disclosed that the United States Department of Justice is conducting a False Claims Act investigation in connection with the marketing of Nuplazid, Acadia Pharmaceutical’s drug approved three years ago to help treat Parkinson’s patients suffering from debilitating psychosis.

The Food and Drug Administration (FDA) approved Nuplazid in 2016 despite a report from a government medical reviewer that the benefits of the antipsychotic medication do not outweigh risks in taking the drug.  The FDA, however, determined otherwise given that it is the only drug targeting psychosis associated with Parkinson’s disease. As of April 2018, more than 700 deaths linked to Nuplazid had been reported to an FDA adverse events database since the drug’s approval in 2016. As a result, the FDA conducted an additional evaluation of Nuplazid, but didn’t find any new safety issues with the drug.

Like other atypical antipsychotics, Nuplazid contains a “black box” warning that those with Parkinson’s disease taking the drug have a higher risk of death.

It is unclear what prompted the government’s investigation. False Claims Act cases are often begun by whistleblowers, who can use the Act to sue defendants for fraud on behalf of the government – and obtain rewards if those lawsuits result in recoveries.

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