In response to the CNN.com article published on December 4, Avanir stands proudly behind the following statement

December 12, 2017

We vehemently oppose any mischaracterization of how Avanir and other members of the pharmaceutical industry interact with the medical community, including physicians that educate other health care professionals about medicines.  Patients and doctors want options for treatment and pharmaceutical companies engage physicians in ways that are both ethical and appropriate to convey the state of medical conditions and FDA-approved treatments that could otherwise remain unknown to patients in need.  Such relationships allow research companies, physicians, and other health care professionals to share first-hand knowledge and raise awareness of medicines that could improve patient conditions.

To this end, Avanir works with doctors across the nation with medical expertise, knowledge, and experience in an effort to advance effective treatment options for people suffering from central nervous system disorders.  Our medical department has in place a robust physician-verification system, which we continually work to refine, to determine if a physician has been disbarred, accurately represented his or her qualifications, and continues to maintain his or her fitness for practice.  We also rely on the judgments of medical boards, who have responsibility for determining whether a physician is fit to practice and may maintain a medical license.  We are committed to educating physicians about the safety, efficacy, and approved uses of our products.  In doing so, we seek to comply with applicable FDA regulations and the standards and laws set by other federal and state bodies.  We stand proudly by our work and are dedicated to the patients we serve.

Below are some additional facts about PBA and NUEDEXTA®:

  • NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) is the first and only FDA-approved drug for the treatment of pseudobulbar affect (PBA).  Doctors who have prescribed NUEDEXTA and seen the positive results have the best background to educate others.  Patients taking NUDEXTA have told us we’ve given them hope and improved their lives.

  • PBA (PseudoBulbar Affect) occurs secondary to a variety of otherwise unrelated neurologic conditions, such as stroke, traumatic brain injury, Alzheimer’s disease and other dementias, multiple sclerosis, and ALS or Lou Gehrig’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

  • Healthcare providers often overlook PBA – it can be confused with other conditions or the symptoms of PBA might be characterized as something else.  Because PBA is often ignored or misdiagnosed, Avanir is committed to raising awareness by educating doctors, patients and family members about this condition.  We want patients and their caregivers to know there is an approved medication specifically for people who suffer from PBA – we want them to understand the symptoms and to feel comfortable talking to their doctors about PBA.

  • Like other drug companies, we work with doctors to help educate the public and patients about the conditions our medications treat.  The reimbursement we and other pharmaceutical companies pay to doctors is based on the fair market value for the speaking arrangement.

  • When working to provide doctors with truthful, accurate, and balanced information so they can decide on the proper treatment for their patients, Avanir seeks to comply with applicable FDA regulations and the standards and laws set by other federal and state bodies.  Avanir has also voluntarily adopted the “Code on Interactions with Healthcare Professionals” from the Pharmaceutical Research and Manufacturers of America (PhRMA).

1 NUEDEXTA Important Safety Information

CONTRAINDICATIONS:

  • 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.

ADVERSE REACTIONS

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.