Nudextra or Dextromethorphan-quinidine is an FDA approved medication for pseudobulbar affect according to studies conducted in patients with ALS or amyotrophic lateral sclerosis as well as people with multiple sclerosis. Nudextra is also prescribed to patients with other underlying disorders.
Some patients received Nudextra had multiple sclerosis (8.4%) or amyotrophic lateral sclerosis (6.8%). More or less of the patients that were prescribed with this drug had Parkinson's or dementia, according to specialists from Brigham and Women's Hospital in Boston. The study shows that this drug is primarily given to patients that are suffering from Parkinson's disease or dementia.
To know more about ALS, visit https://en.wikipedia.org/wiki/Amyotrophic_lateral_sclerosis.
The truth is, this is very alarming because few studies proving the effectiveness as well as the safety of the drug when used for patients. It is crucial for physicians to know that this medication was designed to help patients with MS and ALS. There are almost no data that will support their healing effects on patients with no ALS or MS. The drug is associated with numbers of side effects that include UTI or urinary tract infection, falls as well as confusion or disorientation.
In 2010, the United States Food and Drug Administration approved the combination of quinidine sulfate and dextromethorphan hydrobromide to treat the pseudobulbar affect, where patients experienced a sudden and uncontrollable crying or laughing. The medication's trial was conducted to 326 patients with an average age of 52 that have MS and ALS over 12 weeks.
Giving this drug to patients with PBA or Pseudobulbar Affect associated with other underlying conditions isn't technically off-label, but the approval doesn't restrict the indications exclusively to ALS and MS patients. After the approval of the Food and Drug Administration, Avanir Pharmaceuticals, maker of Nuedexta, rolled out a considerable amount of advertising campaigns. That includes TV commercials that feature actor Danny Glover.
The ad campaign is designed to generate awareness of PBA or pseudobulbar affect and subsequent advertisements calling on all the consumers to ask their doctors about the possible treatment (Nuedextacost is sometimes the least of the patient's concerns).
PBA is diagnosed clinically, usually with the help of patient-reported questionnaires. A few years ago, CNN reported that a lot of insurance companies started to monitor disreputable or malicious prescription of Nudextra or Dextromethorphan-quinidine after there have been concerns about the medication being marketed too aggressively for patients with dementia and Parkinson's disease.
A real PBA is very rare, according to experts. When we are talking about the financial aspect of the drug, it makes a lot of sense if the insurance companies will try to expand the diagnosis to include the number of people for which the treatment is not fit, but the marketing promotion is unethical.
One of the most active components of Nuedexta is dextromethorphan. It is usually found in a lot of cough syrup. Another element that was added to the drug is Quinidine. It is to help prolong the effect of the medication. Unfortunately, quinidine is also an anti-malarial and anti-arrhythmic drug that can also cause heart problems like cardiac arrhythmias.
A few years ago, a ten-week phase two trial of 220 patients that suffers Alzheimer's disease showed that the drug could reduce agitation scores from one to two points over placebos on a no symptom (0) to daily severe symptoms (12) scale.
Most clinical trial participants who received dextromethorphan-quinidine or Nuedexta experienced a higher rate of falls by 8.6% vs. 3.9%, UTI with 5.3% vs. 3.9% and serious adverse effects with a 7.9% vs. 4.7% value compared to placebos. In 2015, the prescription information was updated to eliminate a statement where data in patients who have dementia are lacking.
With new studies, experts looked at patients that were prescribed with Nuedexta in two insurance databases from October 2010 to March 2017 with OptumClinformatics Data Mart records and December 2015b with the Truven Health MarketScan database. Since most commercial insurance records include patients below the age of 65, the researchers also covered the analysis of 2011 to 2016 data from Medicare Part D.
With commercial health insurance records, more or less 12,000 were prescribed with Nuedexta. The average age of the patients in the clinical trial is 66 years old with 13.3% of them had a history of heart failure (which is also a contraindication for Nuedexta).
At least 38% were prescribed with QT-prolonging medication for 30 days. When the results from both databases combined, at least 8.4% of the clinical trial patients are diagnosed with MS, at least 6.8% had ALS, and half of them had either Parkinson's disease or dementia (or both). Researchers found the same pattern before the label of the drug was updated in 2015. Click here for more information about Multiple Sclerosis.
The studies also have limitations according to experts. The reason why Nuedexta or dextromethorphan-quinidine was prescribed to patients is still unknown. Patients that are living in care facilities, as well as older adults, usually are not appropriately represented in insurance claim databases. That is why most researchers have underestimated the degree of prescribing the medication to patients with Parkinson's disease and dementia.