Avanir Pharmaceuticals has gained access to veteran’s medical records through an alliance with the Department of Veterans Affairs (VA) and United BioSource. The goal of the collaboration is to screen for pseudobulbar affect (PBA) symptoms in approximately 1,000 veterans with traumatic brain injury (TBI). Avanir’s Nuedexta was approved by the FDA in 2010 as a treatment for pseudobulbar affect.
PBA occurs when a TBI or other neurological condition, such as multiple sclerosis, Lou Gehrig’s disease, Parkinson’s disease, stroke, or Alzheimer’s disease, damages the areas of the brain that controls normal emotional expression, causing uncontrollable episodes of crying or laughing. These outbursts are often contrary or exaggerated to the patient’s inner emotional state, causing them to laugh or cry when they may not find the situation to be particularly funny or sad.
“This is the first study prospectively assessing PBA symptoms in veterans with TBI,” said Randall Kaye, M.D., chief medical officer at Avanir Pharmaceuticals. “This research will provide key insights including the estimated prevalence of PBA symptoms in this population.”
According to the company, it intends to use the information gathered to develop a screening protocol for identifying and treating PBA symptoms to improve the quality of care for our nation’s veterans.
Nuedexta is a combination of two well-characterized components: dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor that enables dextromethorphan to reach therapeutic concentrations. Nuedexta acts on sigma-1 and NMDA receptors in the brain and spinal cord. The mechanism by which it exerts therapeutic effects in patients with PBA is unknown.