FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Avanir Agrees to $116 Million Settlement for Alleged Kickbacks

Oct. 9, 2019
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Otsuka subsidiary Avanir Pharmaceuticals agreed to pay approximately $116 million to settle whistleblower allegations that the company offered kickbacks to doctors and salespeople to push Nuedexta off label for dementia patients.

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) is only approved for treatment of pseudobulbar affect, a disorder in which symptoms include uncontrollable laughing and crying. Although the drug has not been extensively tested in nursing homes, Avanir has been illegally and heavily marketing Nuedexta to this patient population, the whistleblowers said.

Avanir admitted to paying a doctor “to induce him to not only maintain but increase his prescription volume” of the drug. Four individuals, including a top Nuedexta prescriber and three former Avanir employees, were involved in the kickback scheme and have been indicted.

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