Avanir affirms the following facts and provided a statement in light of November 2 CNN article
- We stand proudly by our commitment to research and development of treatments for CNS disorders and our relationships with advocacy organizations in our overarching commitment to help and support these patients and care communities. Our donations and support assist these organizations in their efforts to provide for patient needs.
- Our financial support of foundations, education and advocacy for patients is entirely proper and is in line with the PhRMA Principles on Interactions with Patient Organizations. We don’t ask or expect any advocacy group to promote or recommend our products, nor is our support intended to influence the patient’s treatment choice.
- Alzheimer’s disease is one of the more common underlying neurological conditions associated with PBA. NUEDEXTA®(dextromethorphan hydrobromide and quinidine sulfate) was approved in 2010 by the FDA for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, such as Alzheimer’s disease. PBA 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.1
Avanir provided the following statement to CNN in advance of the article:
Avanir Pharmaceuticals is proud to be a pioneer dedicated to serving patients by developing innovative treatments to address unmet medical needs related to Central Nervous System (CNS) disorders. Our research efforts and pipeline reflect our desire to help patients with a wide range of neurologic and psychiatric indications, including, for example, Alzheimer’s disease, residual schizophrenia, and traumatic brain injury behavioral dysfunction. In conducting this research, we also engage regularly with patient advocacy, research, and other health-related non-profit organizations because they help us learn and better understand patient and caregiver needs. In the pursuit of these efforts, Avanir takes care to comply with the law and regulations of the FDA and other federal and state bodies.
Our vision is to transform the treatment of CNS diseases by developing and delivering medicines that bring relief to patients and their care communities. At Avanir, we are grounded in science, driven by innovation, and inspired by the people that benefit from our treatments—now and in the future. It is our mission to develop first-in-class medicines that bring meaningful relief to people with neurologic diseases—a benefit that is shared with their families, caregivers, healthcare providers and communities.
1NUEDEXTA Important Safety Information
• Concomitant use with quinidine, quinine, or mefloquine, with drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide).
• Patients with known hypersensitivity to dextromethorphan, or with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions.
• Use with an MAOI or within 14 days of stopping an MAOI. Allow 14 days after stopping NUEDEXTA before starting an MAOI.
• Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure.
• Complete atrioventricular (AV) block without implanted pacemaker, or patients at high risk of complete AV block.
WARNINGS AND PRECAUTIONS:
• Thrombocytopenia or other hypersensitivity reactions or Hepatitis: Discontinue if occurs.
• QT Prolongation: Monitor ECG if concomitant use of drugs that prolong.
• QT interval cannot be avoided or if concomitant CYP3A4 inhibitors used.
• Left ventricular hypertrophy (LVH) or left ventricular dysfunction (LVD): Monitor ECG in patients with LVH or LVD.
• CYP2D6 substrate: NUEDEXTA inhibits CYP2D6. Accumulation of parent drug and/or failure of metabolite formation may decrease safety and/or efficacy of concomitant CYP2D6 metabolized drugs. Adjust dose of CYP2D6 substrate or use alternative treatment when clinically indicated.
• Dizziness: Take precautions to reduce falls.
• Serotonin syndrome: Use of NUEDEXTA with selective serotonin reuptake inhibitor (SSRIs) or tricyclic antidepressants increases the risk. Discontinue if occurs.
• Anticholinergic effects of quinidine: Monitor for worsening in myasthenia gravis and other sensitive conditions.
The most common adverse reactions (incidence of ≥ 3% and two-fold greater than placebo) in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.