Avanir Pharmaceuticals has agreed to pay over $95 million to resolve kickback allegations as well as "false and misleading" marketing of the drug Nuedexta in long-term care (LTC) facilities in a bid to get providers to prescribe it off-label for patients with dementia, the US Department of Justice (DOJ) reports.

"Kickbacks have the power to corrupt a provider's medical judgment," Jody Hunt, assistant attorney of the DOJ's Civil Division, said in a news release. "And it is particularly concerning when a pharmaceutical company uses kickbacks to drive up sales in connection with a vulnerable population, such as elderly patients in nursing care facilities."

Nuedexta, a combination of dextromethorphan hydrobromide and quinidine sulfate, is approved by the US Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA), a condition characterized by involuntary, sudden, and frequent episodes of laughing or crying that occurs secondary to a neurologic disease or brain injury.

The government alleged that Avanir paid physicians and other healthcare providers to write prescriptions for Nuedexta, with payment provided in the form of money, honoraria, travel, and food.

In particular, the DOJ said Avanir sought to capitalize on efforts by the Centers for Medicare & Medicaid Services (CMS) to reduce the use of antipsychotics in patients with dementia in LTC facilities because of concerns that these drugs may be used as a form of chemical restraint in patients.

Avanir told its sales force to start discussions in LTCs regarding antipsychotic use and how Nuedexta could be used to reduce an LTC facility's reliance on antipsychotics "even though Avanir's own studies demonstrated that the actual population of patients with PBA is limited," the DOJ said.

The strategy worked, and use of Nuedexta in LTC facilities increased, the DOJ said.

In one example of the impact of these strategies, the government said an Avanir employee reported that one doctor had "entire units" of patients on Nuedexta at his LTC facility, which contained a large number of patients with dementia who had behavioral issues.

According to the DOJ, the Northern District of Ohio has indicted four individuals in the state, including former Avanir employees, who paid or received kickbacks from Avanir. "All four are charged with conspiracy to solicit, receive, offer and pay healthcare kickbacks. Avanir has agreed to cooperate in the prosecution of these individuals," the DOJ said.

"Doctors should prescribe medicine based on what is best for their patients, not on which drug company is paying for their travel and meals," Justin Herdman, US Attorney for the Northern District of Ohio, said in the release.

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