Pseudobulbar affect (PBA) is associated with various types of neurologic diseases and injuries, including MS, amyotrophic lateral sclerosis (ALS), stroke, and traumatic brain injury (TBI). Individuals who suffer from this symptom experience uncontrolled, inappropriate, and/or exaggerated episodes of crying, laughing, or other emotional display. PBA occurs involuntarily with little or no stimulation to invoke such a response. It can greatly impact social situations and overall quality of life, both for the patient and his or her family. When not recognized as PBA, patients have been misdiagnosed with (and treated for) depression, bipolar disorder, generalized anxiety disorder, personality disorder, and sometimes even epilepsy.
Nuedexta® (dextromethorphan hydrobromide and quinidine sulfate) is an oral drug in capsule form that was approved by the United Sates Food and Drug Administration (FDA) in 2010 for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including multiple sclerosis (MS). Initially, a patient is given one capsule daily for the first seven days. Beginning on the eighth day, the medication is increased to the full dose of two capsules daily (one capsule every 12 hours). No one should take more than two capsules within a 24-hour period, and if a dose is missed, it will need to be skipped, as two doses should never be taken at the same time.
In studies with Nuedexta, episodes of excessive crying and laughing were significantly reduced in the treated group as compared to placebo, both in terms of frequency and severity. According to Avanirn Pharmaceuticals (the makers of Nuedexta), the response to this drug is readily observable within a short time – often within the first week. In the most recent clinical trial (the STAR trial), about half of the patients with PBA experienced a complete remission of this symptom by the end of the study while taking Nuedexta. Scores on a scale measuring emotional lability (the Center for Neurologic Studies Lability Scale [CNS-LS]) were also significantly decreased. The approval of Nuedexta came after 10 years of research and development.
Serious side effects include possible changes in heart rhythm, and the drug may be contraindicated for individuals with a history of certain heart conditions. Patients will need to discuss any heart issues as well as current medications with their physician. Please refer to MSAA’s article on the approval of Nuedexta for complete information on study results and potential side effects.
|Last Updated on Tuesday, 29 January 2013 12:54|