Acadia faces US federal probe into Nuplazid marketing

Acadia Pharmaceuticals may have thought it got out of trouble last year after an FDA safety investigation into its flagship Parkinson’s drug Nuplazid revealed no new risks – but documents have emerged showing the US Department of Justice has launched a separate probe into its marketing.

Nuplazid (pimavenserin) was first approved in April 2016 for psychosis associated with Parkinson’s disease, and although it was the first drug approved to treat the condition, marketing it has hardly been easy for Acadia.

The latest drama at the San Diego-based biotech comes after CNN uncovered documents, alerting shareholders to an investigation by the US Department of Justice into the sales and marketing of Nuplazid.

The filings with the Securities and Exchange Commission financial regulator began in November when Acadia disclosed it had received a civil investigative demand, requesting documents and information under the False Claims Act.

The Federal government uses this legislation to recoup fraudulent gains and the company provided no further information, other than that the investigation began in September.

However, CNN noted that the experts it interviewed suggested the DoJ must have “strong evidence of wrongdoing”.

The company’s annual report stated: “In September 2018 the company received a civil investigative demand (“CID”) from the Department of Justice (“DOJ”) requesting certain documents and information related to the company’s sales and marketing of Nuplazid.

“The company is cooperating with the DOJ’s request. Responding to the CID will require considerable resources and no assurance can be given as to the timing or outcome of the DOJ’s investigation.”

The FDA issued a statement in September reaffirming that there were no new safety issues with Nuplazid other than those outlined in a “black box” warning highlighting increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis.

The regulator issued the statement after re-examining evidence in the light of press reports raising concerns about the drug’s safety, which have caused its share price to fluctuate wildly.