Avanir Pharmaceuticals is the only therapy that the U.S. Food and Drug Administration has approved for pseudobulbar affect, or PBA.
How Nuedexta works
The hallmarks of PBA are sudden and uncontrollable laughing or crying that is not associated with a person’s actual emotional state. Because it can occur at inappropriate times and is not under the patient’s control, it can be distressing for patients and their families.
PBA is caused by damage or dysfunction in the part of the brain that controls emotional expression. It can stem from Parkinson’s or other neurodegenerative diseases, or brain injuries.
Nuedexta is a combination of the compounds dextromethorphan HBr and quinidine sulfate that is taken orally as a tablet. The exact mechanism by which Nuedexta reduces PBA symptoms is unknown. Scientists think it may affect glutamate signaling in the brain. Glutamate is a neurotransmitter or cell signaling molecule.
Several clinical trials have shown that Nuedexta reduces PBA patients’ crying and laughing episodes.
Nuedexta in clinical trials
A large clinical trial (NCT00056524) evaluated Nuedexta’s safety as a PBA treatment, and patients’ ability to tolerate it. The results showed that patients with a variety of neurological conditions, including Parkinson’s, could use it safely long-term.
A Phase 1 clinical trial (NCT03381664) is evaluating how well patients can absorb different versions of Nuedexta. One version is a tablet, another is mixed with applesauce, and still another is delivered by a tube from the nose to the stomach. Researchers continue to recruit healthy volunteers for the U.S. study.
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