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Avanir Pharmaceuticals Announces Publication of Study Evaluating the Prevalence of Pseudobulbar Affect (PBA) Symptoms and Use of Antipsychotic Medications in Nursing Homes
Date:12/1/2015

ALISO VIEJO, Calif., Dec. 1, 2015 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. today announced that data on the prevalence of symptoms for pseudobulbar affect (PBA), a distressing condition characterized by sudden and uncontrollable outbursts of laughing and/or crying resulting from certain neurologic diseases or brain injury (TBI), and the use of antipsychotic medications in nursing home residents, were recently published in the International Journal of Geriatric Psychiatry. The study showed that almost one in 10 (9.0%) nursing home residents had symptoms suggestive of PBA and that patients with PBA symptoms were twice as likely to be receiving antipsychotic medications (p=0.015) even though patients with the diagnosis of psychosis were excluded from the sample assessed. In a subset of these residents who had neurological disorders affecting the brain, 17.5% were found to have symptoms suggestive of PBA.

"While the underlying conditions that can cause PBA are common in nursing home residents, the prevalence of PBA symptoms in this population has never been studied directly. This is the first study that has allowed us to screen for PBA symptoms and then investigate real-world treatment patterns, giving us some of the first insights into the prevalence of PBA in nursing home residents," said Joao Siffert, MD, chief medical officer at Avanir. "It is critical that we have a better understanding of the prevalence of PBA in this population given that PBA is a treatable neurological condition that is often confused with mood disorders or misdiagnosed. Better identification and diagnosis of patients with PBA are important in the care of nursing home residents."

"This study also showed that the use of antipsychotics in nursing homes is higher in patients with PBA symptoms compared to those without. Additional studies are needed, but these data suggest potentially inappropriate off-label use of antipsychotic medications in nursing home residents for the treatment of PBA," said Kevin Foley, MD, FACP, director of education and clinical operations and associate professor, division of Geriatric Medicine at Michigan State University, Department of Family Medicine, College of Human Medicine. "PBA diagnosis and management are important in this patient population given the negative impact PBA can have on social function, psychological well-being and quality of life. However, overlap with co-morbid psychiatric disorders and depression pose challenges for adequately identifying and managing PBA. As a result, antipsychotics, anxiolytics, and other psychopharmacological medications are often used to manage PBA symptoms despite the lack of substantial evidence supporting their off-label use for this condition."

About the Study Design
This observational study was conducted between 2013 and 2014 and assessed 811 residents of nine nursing homes in Michigan using their Minimum Data Set (MDS), version 3.0 data in order to identify the subset of residents at risk for PBA and to evaluate use of psychotropic medications, including antipsychotics. A subset of this sample (412 residents) was considered predisposed to PBA symptoms if they had a documented diagnosis of a neurological disorder associated with PBA, including dementia, stroke, Parkinson's disease, multiple sclerosis as well as other neurological conditions. Patients with an existing diagnosis of psychosis, delirium or other disruptive behaviors were excluded. A series of screening tools were used by a geropsychologist to assess the predisposed population including the Center for Neurologic Study-Lability Scale (CNS-LS), a research tool for the assessment of PBA symptoms; a diagnostic evaluation checklist designed to provide context for the potential PBA symptoms; and a chart review to determine use of psychopharmacological medications. The demographics of the resident population evaluated for this study were similar to that of the overall nursing home population, although there were significantly more patients with dementia in the nursing homes evaluated in the study.

Study Results
Over half of the residents (51%) had a neurologic condition known to be associated with PBA. Of this population, 72 residents (17.5%) had a CNS-LS score of ≥13 (the instrument's range for clinical PBA), which represents 9.0% of the total nursing home resident population. Approximately twice as many residents were prescribed antipsychotic medications (25.0%) compared to residents without PBA symptoms (13.5%), despite the fact that they had no diagnosis of psychosis. Similar results were seen with anxiolytic medications with 25% of residents with PBA symptoms receiving treatment compared to 14.1% of residents without PBA symptoms. Antidepressant use was common in both groups but the differences between those with and those without PBA symptoms was not statistically significant (62.5% vs. 53.2%, p = 0.151).

About PBA
PBA is a neurologic condition characterized by uncontrollable, disruptive laughing and/or crying outbursts that are often contrary or exaggerated to the patient's inner mood state. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury (TBI), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, stroke and Alzheimer's disease. When these disorders damage areas of the brain that regulate normal emotional expression, they can lead to uncontrollable, disruptive episodes of crying or laughing. For more information about PBA, please visit www.PBAFacts.com.

About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com.  

Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.'

Otsuka Pharmaceutical is a leading firm in the challenging area of mental health and also has products and research programs for several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical and its affiliates employ approximately 30,000 people globally, and the company welcomes you to visit its global website at: http://www.otsuka.co.jp/en/index.php  

Avanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.

©2015 Avanir Pharmaceuticals, Inc. All Rights Reserved.

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