Nuedexta is an oral medication approved by U.S. Food and Drug Administration (FDA) to treat pseudobulbar affect (PBA), a condition characterized by sudden and unpredictable episodes of crying or laughing seen in people with amyotrophic lateral sclerosis (ALS) and other neurological conditions.
How Nuedexta works
PBA occurs when certain areas of the brain responsible for controlling emotions are damaged. Nuedexta contains two compounds called dextromethorphan and quinidine. Even though the exact mechanism of action of Nuedexta in helping to treat PBA is unknown, it is believed that it works by acting on areas of the brain that control the functions of the bulbar muscles (those of the mouth and throat responsible for speech and swallowing).
Nuedexta in clinical trials
Nuedexta has been investigated for its safety and effectiveness in numerous clinical trials. For example, a randomized Phase 2 trial (NCT01806857) investigated whether Nuedexta was effective in treating ALS symptoms such as impaired, speech, swallowing, and saliva control. The results of the study, published in the journal Neurotherapeutics, revealed that Nuedexta improved patients’ speech and swallowing.
Nuedexta also has been investigated in numerous studies in treating PBA in patients with ALS. For example, a Phase 3 clinical trial (NCT00573443) evaluated the safety, tolerability, and effectiveness of two different doses of Nuedexta in treating PBA in patients with ALS. The results of the study, published in the scientific journal Annals of Neurology, revealed that Nuedexta markedly reduced the frequency and severity of PBA among patients who participated in the study.
The safety of Nuedexta also was investigated in another Phase 3 trial (NCT00021697) for the treatment of PBA in patients with ALS. The results of the study, published in the scientific journal Neurology, revealed that Nuedexta was effective in reducing episodes of crying and laughing, and in improving the overall quality of life and relationships of patients with ALS.
The long-term safety of Nuedexta in treating PBA associated with several other neurological conditions was investigated in an open-label, multicenter Phase 3 study (NCT00056524). The results, published in the journal Current Medical Research and Opinion, revealed that Nuedexta was well-tolerated in patients with PBA.
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