In response to the CNN article published on June 4th, Avanir stands behind the following statement

June 19, 2018

The article published by CNN on June 4th contains several mischaracterizations and inaccuracies regarding Avanir and NUEDEXTA.  For example, the article confuses warnings with alerts, portrays its own allegations as findings and characterizes education materials, commonly known within the industry as slim jims, as snacks. What’s more, the allegations of off label promotion referenced in the 2012 Blue Cross Blue Shield letter relate to a misinterpretation that NUEDEXTA was only approved for the treatment of pseudobulbar affect (PBA) for individuals diagnosed with PBA in limited settings. To clarify that issue, in 2015 the FDA approved a change in the indication statement, which confirmed NUEDEXTA is approved for use in treatment of PBA in all settings in which it occurs.  
 
We take mischaracterizations about our products seriously and are committed to educating physicians about the safety, efficacy, and approved uses of our products. The safety profile of NUEDEXTA has been studied by Avanir in multiple neurological disorders associated with PBA (including traumatic brain injury, stroke, Parkinson’s disease and dementia) and is consistent with what was approved by the FDA and reflected in the NUEDEXTA label. We seek to comply with applicable FDA regulations and the standards and laws set by other federal and state bodies.  
 
An estimated 2 million people in the United States suffer from PBA. NUEDEXTA remains the only FDA-approved treatment for PBA.
 
The full text of our initial statement provided to CNN is below:
 
NUEDEXTA® was approved in 2010 for the treatment of pseudobulbar affect (PBA) irrespective of the underlying neurological disease. PBA is a distinct neurologic condition characterized by uncontrollable, involuntary, sudden and frequent episodes of laughing and/or crying that typically occur out of proportion or incongruent with the underlying emotional state. PBA occurs secondary to a variety of neurologic disorders, including but not limited to people with Parkinson’s disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, Alzheimer’s disease, other dementias, or traumatic brain injury. Therefore, it is inaccurate to say that NUEDEXTA was approved only for use in the treatment of PBA in ALS and MS populations.
 
To eliminate confusion in product labeling, in 2015 the FDA approved a change in the indication statement. This change confirmed NUEDEXTA is approved for use in treatment of PBA in all settings in which it occurs.  Accordingly, the NUEDEXTA label reads:
 
“NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.”
 
Avanir is committed to the safe, effective use of NUEDEXTA for the treatment of patients with PBA, consistent with the FDA approved product labeling and regulatory standards. We take seriously our role in educating patients, caregivers and health care providers about NUEDEXTA and PBA and we engage with CMS to ensure communications regarding the use of NUEDEXTA accurately reflect FDA approved labeling. Our NUEDEXTA promotional materials, including informational pamphlets used in physician offices and medical facilities, are subject to internal review and submission to the FDA, and are consistent with Avanir’s Comprehensive Compliance Program and Code of Business Conduct and Ethics.
 
Avanir is likewise committed to ensuring that patients with neurologic diseases who suffer from PBA have access to treatment. We also work with payors to facilitate patient access to care and to approve treatment for patients with PBA. It is common that CMS, health insurers or other payors request prior authorization before a patient receives treatment – this is not unique to PBA or NUEDEXTA (e.g., this report shows that nationwide, over a six-year period, total restrictions in select therapeutic classes increased nearly two-fold, from 41% to 76%).
 
NUEDEXTA is the only available FDA approved treatment for PBA.