In a Los Angeles nursing home last year, regulators found that more than a quarter of its residents – 46 of 162 – had been placed on Nuedexta, noting that a facility psychiatrist had given a talk about the drug to employees. “There is little to no medical literature to support the drug’s use in nursing home residents (with dementia) – the population apparently being targeted.”ĬNN identified dozens of cases across the country since 2013 in which state nursing home inspectors questioned the use of Nuedexta. “There has to be a diagnosis for every drug prescribed, and that diagnosis has to be real … it cannot be simply made up by a doctor,” said Kathryn Locatell, a geriatric physician who helps the California Department of Justice investigate cases of elder abuse in nursing homes. And state regulators have found doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta to treat patients whose confusion, agitation and unruly behavior make them difficult to manage. But geriatric physicians, dementia researchers and other medical experts told CNN that PBA is extremely rare in dementia patients several said it affects 5% or less. Nuedexta is approved by the Food and Drug Administration (FDA) to treat anyone with PBA, including those with a variety of neurological conditions such as dementia. A company website states PBA can afflict up to roughly 40% of dementia patients – a figure that is based on an Avanir-funded survey and was repeatedly disputed by medical experts interviewed by CNN, including some of those paid by Avanir. In an emailed statement, the company said PBA is often “misunderstood” and that the condition can affect people with dementia and other neurological disorders, which are common among residents in long-term care facilities. The one study the company conducted solely on patients with Alzheimer’s (a type of dementia) had 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.Īvanir declined repeated requests to be interviewed for this article. Nuedexta is being increasingly prescribed in nursing homes even though drugmaker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients – prompting critics to liken its use to an uncontrolled experiment. Total sales of Nuedexta reached almost $300 million that year. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. In her former nursing home, Lenore Greenfield was diagnosed with PBA and prescribed Nuedexta by California psychiatrist Romeo Isidro, a physician who has received hundreds of thousands of dollars in promotional payments from Avanir. Nuedexta’s financial success, however, is being propelled by a sales force focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company, CNN found. This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker’s own figures, and it is most commonly associated with people who have multiple sclerosis (MS) or ALS, also known as Lou Gehrig’s disease. The pill, called Nuedexta, is approved to treat a disorder marked by sudden and uncontrollable laughing or crying – known as pseudobulbar affect, or PBA. The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe, a CNN investigation has found.Īnd much of the money is coming straight from the federal government.

Red pill with i 2