Avanir released the following statement in response to an article published by CNN
PBA is a neurological condition that affects up to an estimated 2 million Americans, but can be misunderstood by patients and their families. When someone with PBA has an intense laughing or crying episode, he or she can feel powerless, embarrassed, or discomforted. PBA occurs in people who already have a neurological condition, such as ALS, MS, stroke, Alzheimer’s disease, other dementias, or traumatic brain injury. Because neurological disorders commonly occur in residents of long-term care facilities, treatment with NUEDEXTA® can be appropriate for residents in these facilities who also have PBA.
Prior to NUEDEXTA, there were no FDA-approved medications for the treatment of PBA. Obtaining FDA approval is an intentionally rigorous process designed to ensure a medicine’s safety and efficacy. The FDA approves about 1 in 10 New Drug Applications. Avanir spent more than 10 years and hundreds of millions of dollars to conduct extensive clinical studies and bring NUEDEXTA to market. NUEDEXTA has a well characterized safety profile in patient populations with neurological disease or injury.
Our goal is to give doctors truthful, accurate and balanced information so they can decide on the proper treatment for their patients. We are committed to providing information on PBA and NUEDEXTA in ways that are consistent with the law and the values and expectations of the doctors and patients we serve. Our promotional materials are subject to internal review and submission to FDA and Avanir’s Comprehensive Compliance Program, Code of Business Conduct and Ethics, and compliance policies reflect our commitment to an ethical culture.
At Avanir Pharmaceuticals, we are proud to be a pioneer and dedicated to serving patients by developing innovative treatments to address unmet medical needs of people with CNS disorders, and are heavily investing in R&D to achieve this goal. We are committed to raising public awareness of little known disorders such as PBA and developing innovative, first-of-their-kind treatments. Our research and development activities are focused on important unmet needs in the areas of Alzheimer’s disease, Schizophrenia, Traumatic Brain Injury, and Migraine.
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