PseudoBulbar Affect (PBA) affects approximately 2 million people within the United States and much more worldwide. It is a neurological condition and is often associated with different types of brain injuries, including those that occur with a stroke, multiple sclerosis, Parkinson’s disease and Alzheimer’s. The most common symptom of PBA is an uncontrolled and inappropriate laughing or crying. The only FDA approved treatment for the symptoms of PBA is Nuedexta.
Nuedexta contains two primary ingredients, dextromethorphan, and quinidine. These medications have been used separately for the treatment of other conditions, but when used together, they may be able to help reduce or eliminate the symptoms of PBA in some individuals. In clinical trials, it has been shown that it reduced the involuntary laughing and crying that is associated with the condition. In fact, in a 12-week study, patients experienced, on average, 82% fewer episodes of PBA. These results are promising, considering that a placebo only led to a 45% reduction. Over half of the patients had eliminated PBA episodes by the final two weeks of the study.
Avanir Pharmaceuticals is a biopharmaceutical company that is primarily focused on producing medicines that help individuals who have disorders of the central nervous system. One of those medications, available by prescription only, is Nuedexta. In October 2010, Avanir Pharmaceuticals obtained approval for Nuedexta from the US Food and Drug Administration (FDA). Since then, they had also received marketing authorization from the European Union in 2013. As of this date, it is approved for use in the United States, European Union, Norway, and Iceland.
The two different medications in Nuedexta work in conjunction with each other to reduce the symptoms of PBA. Dextromethorphan is commonly prescribed as a cough suppressant on its own. It affects the brain cycles that trigger the reflex of coughing. It is not effective at treating coughing associated with asthma, smoking or emphysema. Quinidine is commonly prescribed on its own as an antiarrhythmic medication to treat conditions such as atrial flutter and atrial fibrillation. It may also be used for the treatment of malaria.
It’s not entirely understood how the combination of medications works to reduce the symptoms of PBA. It is thought, however, that it regulates excitatory neurotransmissions with the Sigma-1 receptor antagonist activity. It may also have an effect on the NMDA receptor antagonist activity as well. This effect is thought to be due to the actions of Dextromethorphan, with Quinidine helping to reduce how quickly the Dextromethorphan breaks down in the brain.
Nuedexta was given FDA approval after a phase III clinical trial. This clinical trial enrolled patients who had multiple sclerosis or Lou Gehrig’s disease. Over the course of 12 weeks, they were either provided with Nuedexta or a placebo. The study was conducted to determine if the crying and laughing episodes could be reduced. The study concluded that those events were reduced significantly by the group that used Nuedexta in comparison to those that used the placebo. A similar study was performed for CHMP approval.
When the drug was first introduced in 2006, the FDA did not give its approval. They felt, at the time, that there were some issues associated with heart rhythm safety. The concern was primarily over quinidine and the possibility that it led to QT prolongation, which could be linked to an increased risk of heart attack. Nuedexta was then reformulated so that a lower dose of quinidine was included. New studies were conducted so that approval could be received.
Although Nuedexta has been prescribed for use in those with PBA, it may also be prescribed for other conditions as well. Some physicians are giving the prescription for agitation associated with Alzheimer’s disease, and it may also be prescribed for severe depression as well. The doctor can make the determination why this medication should be prescribed.
Nuedexta has shown real promise in helping individuals with a critical condition to lead a life that is free of the symptoms. It may also be beneficial for other conditions as well. Talk to your doctor about the possibility of using this medication and discuss your current medication usage and medical history. You may just find that it is the best option for you.