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Nuedexta

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Nuedexta is approved to treat pseudobulbar affect, or PBA, a rare condition that affects just 1% of Americans. However, a recent CNN investigation indicated that the drug’s manufacturer has made millions of dollars marketing Nuedexta for the off-label treatment of elderly nursing home patients suffering from Alzheimer’s disease and dementia.

What Is Nuedexta?

Nuedexta was brought to market by Avanir Pharmaceuticals in 2010, and was the first medication approved by the U.S. Food & Drug Administration (FDA) to treat pseudobulbar affect or PBA.

Nuedexta is a single capsule that combines two active ingredients: dextromethorphan and quinidine. The drug affects the sigma-1 and NMDA receptors in the brain, though it’s no known exactly how the Nuedexta works.

Nuedexta patients initiate treatment by taking 1 capsule per day for seven days. On the eighth day, dosage is increased to 2 pills per day, 1 every 12 hours.

What is Pseudobulbar Affect?

PBA is a disabling neurologic disorder that causes unpredictable emotional outbursts, such as inappropriate episodes of laughing or crying that occur out of proportion or incongruent to an individual’s underlying emotional state.

PBA is generally secondary to another neurologic illness or injury, including multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury.

Studies to support the effectiveness of Nuedexta were performed in patients with underlying ALS or MS. The drug has not been shown to be safe or effective in other types of emotional lability that can commonly occur in Alzheimer’s disease and other dementia patients.

Nuedexta Side Effects

The most common side effects of Nuedexta include:

• Diarrhea
• Dizziness
• Cough
• Vomiting
• Weakness
• Swelling of feet and ankles

Stop using Nuedexta and call your doctor at once if you have:

• Headache accompanied by chest pain and severe dizziness or fainting
• Fast or pounding heartbeats, a sensation of fluttering in the chest
• Easy bruising or bleeding (nosebleeds, bleeding gums)
• Pain or burning when urinating
• Lupus-like symptoms (joint pain or swelling with fever, headaches, confusion, chest pain, shortness of breath, skin sores, butterfly-shaped skin rash on the cheeks and nose, and numbness, cold feeling, or pale appearance of fingers or toes)
• Liver problems, resulting in nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
• High serotonin levels, marked by agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, and fainting

CNN Investigates Nuedexta Off-Label Marketing

An investigative report aired on CNN in October 2017 suggested that Avanir Pharmaceuticals has aggressively marketed Nuedexta to treat elderly nursing home patients with Alzheimer’s disease or dementia.

Expert consulted by CNN maintain that PBA occurs in fewer than  5% of dementia patients. Yet more than half of all Nuedexta pills have gone to long-term care facilities since 2012. The network’s investigation suggested that the drug is often being used off-label to reduce agitation in patients suffering from dementia and Alzheimer’s disease.

As part of its investigation, CNN confirmed dozens of instances across the country since 2013 in which state nursing home inspectors questioned the use of Nuedexta. In one case, a Los Angeles nursing home was using the drug to treat more than a quarter of its patients. The report noted that the facility’s psychiatrist had given a talk about Nuedexta to employees. The doctor was a paid speaker for Avanir.

Between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services. Another t $4.6 million was spent on travel and dining costs, both for speakers and for doctors being targeted by sale reps.

More than 50% of the Nuedexta reimbursement claims filed with Medicare in 2015 were initiated by doctors who had received money or other perks from the Avanir.

Doctors are free to use FDA-approved drugs for any purpose they deem necessary, even for indications that haven’t been approved by the agency. However, pharmaceutical companies are legally prohibited from marketing prescription medications for off-label use.