Avanir Pharmaceuticals Launches New Campaign to Educate Patients and Caregivers by Raising Awareness of the Appropriate Diagnosis and Treatment of PseudoBulbar Affect (PBA).

April 20, 2018

Avanir pharmaceuticals today launched a national, multi-channel campaign aimed at raising awareness of Pseudobulbar Affect, an often ignored and under treated neurologic condition that occurs secondary to certain neurologic injury or disease.

According to a large Harris Poll online survey, approximately two-million people in the United States live with Pseudobulbar Affect (PBA)1. PBA occurs as a result of a primary neurologic disease or injury. Although PBA is not a life threatening condition, it can significantly impact the daily life for those who have or are caring for someone with this condition2

Physicians often mischaracterize PBA as depression or attribute it as an expected outcome of the primary neurologic condition (stroke, Alzheimer’s, dementia, traumatic brain injury, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease). Patients and caregivers, busy adjusting to life after the onset of their neurologic disease or injury, often assume that treatment for this condition isn’t available or isn’t necessary if their clinician didn’t talk with them about it3

PBA has been documented to impact both patients’ and caregivers’ daily life. PBA episodes of frequent, sudden, uncontrollable laughing and crying - often exaggerated or simply not matching how the person feels - take a toll on both patients and caregivers. This lack of predictability and control has been shown to lead to increased interpersonal misunderstanding, embarrassment and vulnerability – sometimes influencing their degree of socialization2.

PBA is just one of the many secondary health issues that challenge patients and caregivers living with neurologic disease or brain injury. PBA is treatable. To-date, less than 10% of patients with PBA have been appropriately treated for this condition.4 Avanir is committed to increasing education about the only FDA-approved treatment for PBA, NUEDEXTA (dextromethorphan HBr and quinidine sulfate) 20 mg/10mg capsules, proven safe and effective with over 1 million prescriptions filled during the past seven years.4 

For more information about PBA and NUEDEXTA, including a short quiz that can help start a conversation with a physician about PBA, please visit www.NUEDEXTA.com   

WHAT IS NUEDEXTA® APPROVED FOR?
•    NUEDEXTA is approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury.
•    NUEDEXTA is only available by prescription.


IMPORTANT SAFETY INFORMATION


Before you take NUEDEXTA, tell your doctor:


•    If you are taking monoamine oxidase inhibitors (MAOIs), quinidine, or quinidine-related drugs. These can interact with NUEDEXTA causing serious side effects. MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.
•    If you have previously had an allergic reaction to dextromethorphan, quinidine or quinidine-like drugs.
•    About all medicines, herbal supplements, and vitamins you take as NUEDEXTA and certain other medicines can interact causing side effects.
•    If you have had heart disease or have a family history of heart rhythm problems. NUEDEXTA may cause serious side effects, including changes in heart rhythm. If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.
•    If you have myasthenia gravis.


While taking NUEDEXTA, call your doctor right away:


•    If you feel faint or lose consciousness.
•    If you experience lightheadedness, chills, fever, nausea, or vomiting as these may be signs of an allergic reaction to NUEDEXTA. Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.
•    If you have unexplained bleeding or bruising. Quinidine, an ingredient in NUEDEXTA, can cause a reduction in the number of platelets in your blood which can be severe and, if left untreated, can be fatal.
•    If you feel dizzy, since it may increase your risk of falling.
•    If you have muscle twitching, confusion, high blood pressure, fever, restlessness, sweating, or shivering, as these may be signs of a potential drug interaction called serotonin syndrome.
•    The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.
•    You are encouraged to report negative side effects of prescription drugs to the FDA.


Visit www.fda.gov/medwatch or call 800-FDA-1088.


For full prescribing information, visit

https://www.nuedexta.com/sites/default/files/Prescribing_Information.pdf


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 researches, develops, manufactures and markets innovative and original pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.


In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does. Otsuka Pharmaceutical and its related companies, employ approximately 31,000 people worldwide. You can visit the company's global website at https://www.otsuka.co.jp/en.


Edelman Media Contact
Shannon Moore
Shannon.Moore@Edelman.com 
(323) 761-6542 


References


1. Work SS, Colamonico JA, Bradley WG, Kaye RE. Pseudobulbar affect: an under-recognized and under-treated neurological disorder. Adv Ther. 2011;28(7):586-601.


2. Colamonico J, Formella A, Bradley W. Pseudobulbar affect: burden of illness in the USA. Adv Ther. 2012;29:775-798.


3. Data on File. Primary qualitative market research – Physicians, caregivers and patients Avanir Pharmaceuticals, Inc. Aliso Viejo, CA. 2017-2018


4. Data on file. Avanir Sales Reports, Physician primary quantitative market research. Avanir Pharmaceuticals, Inc. Aliso Viejo, CA. 2007-2018.


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