The drug Nuedexta was originally intended to help curb emotional outbursts in patients with progressive neurodegenerative diseases.
More recently, it’s been prescribed to curb outbursts in patients with memory loss disorders.
Now, critics say, the commonly prescribed drug is bringing in millions of dollars to the drug’s manufacturer, thanks to the company’s targeted sales tactics.
was developed by Avanir Pharmaceuticals.
It was by the U.S. Food and Drug Administration (FDA) in 2010 to treat pseudobulbar affect (PBA).
The condition is primarily associated with people who have multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS).
Drug marketed to treat dementia
An by CNN has concluded that Avanir sales teams aggressively targeted doctors and employees at long-term nursing homes to prescribe the drug to their patients that have dementia and Alzheimer’s disease.
The tactic has reportedly proved profitable.
Sales for Nuedexta totaled nearly $300 million in 2016, up 400 percent from 2012, according to the CNN investigation.
“Nuedexta is being increasingly prescribed in nursing homes even though drug maker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients,” the report said.
The Mayo Clinic as a condition characterized by episodes of sudden uncontrollable and inappropriate laughing or crying.
The symptoms usually are seen in people who have neurological diseases such as MS and ALS, as well as those with dementia or who’ve had a stroke.
However, according to the CNN report and health experts interviewed by Healthline, PBA occurs in about 5 percent of people with dementia.
CNN reported that Avanir investor documents reveal that just “100,000 of the 1.8 million patients who have PBA live in long-term care homes.”
Dr. Eric Widera, a professor at the University of California San Francisco (UCSF), specializes in geriatrics.
He told Healthline the agitation that people with dementia and Alzheimer’s tend to experience, such as wandering, anger, and defiance, usually stems from an internal stimulus.
PBA is rarely the root cause.
“Maybe they have pain… there could be so many things,” he said. “This drug does not fix it.”
Even though PBA is rarely associated with dementia, that apparently hasn’t stopped Avanir from pushing Nuedexta as treatment for agitation symptoms associated with the disease.
Pushing the drug
Internal documents obtained by CNN showed Avanir’s former chief executive officer telling sales representatives to pursue doctors, nurses, and even pharmacists to identify dementia patients.
The journalists discovered that Avanir sales reps reviewed patients’ charts and hosted training sessions on how to appeal Medicare coverage if the drug was refused by federal officials.
CNN revealed doctors who promoted the drug in exchange for travel and other perks from Avanir. One doctor reportedly received more than $600,000 from the company.
The news organization also found dozens of cases throughout the country where state nursing home inspectors questioned the use of Nuedexta.
In a nursing home in Los Angeles, nearly one-fourth of all patients were prescribed the drug. CNN uncovered that the facility’s psychiatrist was a paid speaker of Avanir.
Nuedexta, which is comprised of the cough suppressant dextromethorphan as well as quinidine, arrived at an opportune time, according to Widera.
For years, nursing homes and doctors prescribed antipsychotics to dementia patients to quell outbursts.
But in recent years, these types of medications have fallen out of favor due to their side effects.
When it comes to caring for patients with dementia, emotional outbursts are the most challenging to control, Widera noted.
That’s true whether you’re a family member or a paid caregiver who works in a long-term care facility. People turn to drugs to help with a stressful situation.
“The agitation,” Widera said, “that’s the hardest part about caring for someone with dementia.”
Getting Medicare to pay
Today, more than half of all Nuedexta pills come from prescriptions for patients in long-term care facilities, according to the CNN report.
The Medicare Part D funding program paid $138 million for the medication in 2015, up 400 percent from 2012.
Medicare Part D will only pay for the drug if the patient is diagnosed with PBA. So-called “off-label” usage isn’t covered. An off-label prescription is when a drug is used for treatment that it’s not approved for by the FDA.
Dr. Angela Hansen, a geriatrician with the University of Washington, has worked with dementia patients for about 10 years.
She said doctors of all persuasions use off-label prescriptions for treatment. Dementia is no different, especially when it comes to treating for agitation.
“There are no drugs that are FDA approved for agitation,” she said. “There are off-label uses, which are fine.”
But any diagnosis designed to fit the requirements needed for Medicare coverage to kick in, regardless of the disease, is troubling, she added.
“We should always be truthful in our diagnoses,” Hansen said.
Looking into the problem
Both Hansen and Widera say in this instance that prescribing Nuedexta as an off-label treatment for agitation is worrisome.
They say the current data isn’t strong enough to support this type of use and that’s why neither has prescribed the drug for their own patients.
Widera points to a Nuedexta drug trial, published in the New England Journal of Medicine, that included about 200 patients with Alzheimer’s.
Nuedexta did produce improvement in these patients, but nearly half who participated also showed “fall risks.”
Widera noted that a fall risk in patients with dementia is life-threatening.
“That’s worrying for this population,” he said. “It doesn’t make me feel like it’s a safe drug.”
Avanir declined to be interviewed by CNN for the story. But in an email, they said that “PBA is often ‘misunderstood.’”
The FDA also declined to speak to CNN about safety issues surrounding Nuedexta, but an official did say that the agency continues to review safety information after a drug is approved.
In an email to Healthline, the FDA said it considers adverse reports and other available information such as “published literature of case reports, epidemiological studies, clinical studies including re-evaluation of data from the clinical development program, manufacturer’s periodic safety reports” to determine if further action is required on any given drug.
The Alzheimer’s Association said in statement to Healthline that the organization has instructed local offices and helpline staff to respond to inquiries about Nuedexta and PBA, so that people can receive accurate information.
“The Alzheimer’s Association does not condone inappropriate prescription of any medication. We understand that PBA can manifest in several neurological diseases, including Alzheimer’s,” the statement said. “We encourage vigorous review and oversight of companies and prescribers to ensure best practices are followed for those impacted by Alzheimer's disease.”
Since the story was published, the Los Angeles officials have opened an investigation into Avanir to “determine whether state or federal laws have been broken in the sale, marketing or prescribing of Nuedexta,” according to a by CNN.
The city attorney also plans to investigate the nursing homes where the drug has been prescribed.
Hansen said a study on Nuedexta, backed by the National Institutes of Health, that showed positive outcomes would make her feel more comfortable in prescribing the medication.
But in the meantime, both doctors say better training of staff and family members who are caring for dementia patients could go a long way.
“The gold standard is training. That’s the best treatment we have,” Widera said. “But that takes a healthcare system that would pay for that.”