Avanir’s no good, awful, simply terrible week came to a disastrous end last Friday as the Otsuka subsidiary was forced to report that its second Phase III trial for a new-and-improved version of its commercial drug had failed in treating Alzheimer’s dementia — likely scuttling any future it may have had in the most difficult of all diseases.
After a yearslong federal investigation over Neudexta marketing and an “agreement in principle” earlier this year, Otsuka’s Avanir has reached a settlement with the feds. The drugmaker agreed to pay more than $108 million to resolve civil and criminal allegations as well as assist in a prosecution against former employees and a top prescriber.
Otsuka has reported positive phase 3 results with a drug intended to calm agitation in patients with Alzheimer’s disease.
Avanir has faced intense scrutiny over its marketing of neurological treatment Nuedexta, and now the company is nearing a deal with the Department of Justice to resolve the government's probe.
For years, the Centers for Medicare & Medicaid Services has been hearing concerns that laughing drug Nuedexta was being aggressively pushed by maker Avenair Pharmaceuticals and some doctors for questionable use on dementia patients. Now, the CMS is asking insurers to be on alert for that kind of suspicious prescribing pattern and to let the agency know ASAP if it has concerns.
Actavis Elizabeth’s Generic Dextromethorphan Hydrobromide;Quinidine Sulfate Receives Approval In US
ALISO VIEJO, Calif., April 19, 2017 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. today announced key data presentations for NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules and ONZETRA® Xsail® (sumatriptan nasal powder) delivery system of 11 mg per nose piece at the 69th American Academy of Neurology (AAN) Annual Meeting in Boston April 22-28.
“We’re shifting the focus and taking the awareness that campaign has built and building on it by turning the conversation to both PBA and treatment with Nuedexta,” Alana Darden, director of consumer marketing at Avanir, told FiercePharma in an interview.