Avanir Pharmaceuticals to Present Data on NUEDEXTA® and ONZETRA® Xsail® at American Academy of Neurology (AAN) 2017 Annual Meeting

ALISO VIEJO, Calif., April 19, 2017 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. today announced key data presentations for NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules and ONZETRA® Xsail® (sumatriptan nasal powder) delivery system of 11 mg per nose piece at the 69th American Academy of Neurology (AAN) Annual Meeting in Boston April 22-28. 

"Data presentations at this year's AAN demonstrate our commitment to developing and commercializing first-in-class medicines that bring meaningful relief to people with CNS disorders," said Richard Malamut, MD, senior vice president, research and development, and chief medical officer, Avanir Pharmaceuticals, Inc. "We are particularly excited about the ONZETRA Xsail data and presenting the results of analyses of treatment differences in migraine pain intensity and consistency of reduced clinical disability between ONZETRA Xsail and sumatriptan tablets. We will also share data demonstrating the persistence of effect of NUEDEXTA in patients treated for pseudobulbar affect (PBA) enrolled in an open-label extension study (STAR OLE)."

NUEDEXTA Presentations

NUEDEXTA was approved by the U.S. Food and Drug Administration (FDA) in October 2010 as the first treatment for pseudobulbar affect (PBA). NUEDEXTA presentations at AAN include concomitant use with antidepressants and a 12-week open-label extension study for adults with PBA. The NUEDEXTA presentations at AAN are:

• "Dextromethorphan/Quinidine Improved Symptoms of Pseudobulbar Affect Irrespective of Concomitant Antidepressant Use" will be presented by Dr. Benjamin Brooks on Friday, April 28 from 8:30 a.m. to 5:30 p.m. in Poster Session 6. P6.210.
• "Persistence of Effect of Dextromethorphan Hydrobromide/Quinidine Sulfate (DM/Q) for Pseudobulbar Affect (PBA): Results from a 12-Week Open-Label Extension (OLE) Study" will be presented by Dr. Alexander on Friday, April 28 from 8:30 a.m. to 5:30 p.m. in Poster Session 6. P6.313.

ONZETRA Xsail Presentations

ONZETRA Xsail was approved by the FDA in January 2016 for the acute treatment of migraine with or without aura in adults. ONZETRA Xsail presentations at AAN include a review of the most common adverse events in the COMPASS study, a pharmacokinetic modeling study on absorption, and two new modeling approaches comparing the impact of ONZETRA Xsail and sumatriptan tablets on pain intensity and clinical disability in migraine across multiple attacks. The ONZETRA Xsail presentations at AAN are:

• "Simultaneously Evaluating Treatment Differences in Mean Level and Consistency in Migraine Pain Intensity Using Location Scale Mixed Effects Modeling: Results from the COMPASS Study" will be presented by Dr. Richard Lipton of Albert Einstein College of Medicine on Monday, April 24 from 8:30 a.m. to 7 p.m. in Poster Session 2. P2.160.
• "Pharmacokinetic Modeling Study to Evaluate Two Intranasal Formulations of Sumatriptan for Nasal vs Gastrointestinal Tract Absorption" will be presented by Mary Lor of Celerion on Monday, April 24 from 8:30 a.m. to 7 p.m. in Poster Session 2. P2.147.
• "Comparing Average Level and Within-person Consistency in Clinical Disability Using AVP-825 vs. Sumatriptan Tablets: Applying Location Scale Mixed-effects Models" will be presented by Dr. Kenneth Shulman of Avanir Pharmaceuticals on Monday, April 24 from 8:30 a.m. to 7 p.m. in Poster Session 2. P2.166.
• "Characterizing the Most Common AEs Following Treatment with AVP-825: Exploring Abnormal Taste and Nasal Discomfort Across Multiple Attacks in COMPASS Study" will be presented by Dr. Kenneth Shulman of Avanir Pharmaceuticals on Monday, April 24 from 8:30 a.m. to 7 p.m. in Poster Session 2. P2.171.

Avanir Pharmaceuticals, Inc. Medical Affairs will be exhibiting at the meeting in Booth #329.

About NUEDEXTA
NUEDEXTA is an innovative combination of two well-characterized components, dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, a metabolic inhibitor enabling therapeutic concentrations of dextromethorphan. Dextromethorphan acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.

NUEDEXTA Important Safety Information
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 crying and/or laughing. 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.

NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules 20 mg/10 mg can interact with other medications, including those metabolized by CYP2D6, causing significant changes in blood levels of those medications and/or NUEDEXTA which may lead to serious side effects. Adjust dose of the other medication or use alternate treatment when clinically indicated.

NUEDEXTA is contraindicated in patients concomitantly taking: QT-prolonging drugs metabolized by CYP2D6 (e.g., thioridazine and pimozide); monoamine oxidase inhibitors (MAOIs) within the preceding or following 14 days; other drugs containing quinidine, quinine, or mefloquine and in patients with a known hypersensitivity (including prior quinidine-induced thrombocytopenia, hepatitis, bone-marrow depression, or lupus-like syndrome) to these drugs or any of NUEDEXTA's components.

NUEDEXTA is contraindicated in patients with certain risk factors for arrhythmia such as: Prolonged QT interval; congenital long QT syndrome, history suggestive of torsades de pointes; heart failure; complete atrioventricular (AV) block or risk of AV block without an implanted pacemaker.

NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose. Risk factors include left ventricular hypertrophy or dystrophy or concomitant use of drugs that prolong QT interval or concurrent use of moderate to strong CYP3A4 inhibitors.

Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal. Discontinue use of NUEDEXTA if thrombocytopenia, hepatitis, serotonin syndrome or a hypersensitivity reaction occurs. Anticholinergic effects have been reported in patients taking quinidine. Monitor for worsening in myasthenia gravis.

NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.

The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.

These are not all the risks from use of NUEDEXTA.

Please refer to the Full Prescribing Information or visit www.NUEDEXTA.com.

About ONZETRA Xsail
ONZETRA Xsail is an intranasal medication delivery system containing sumatriptan, the most commonly prescribed migraine medication. The medication is delivered intranasally utilizing the novel Xsail Breath Powered® delivery technology. ONZETRA Xsail is a fast-acting dry-powder intranasal form of sumatriptan for the acute treatment of migraine. Sumatriptan is the most widely used prescription migraine medication and has been used safely for over 20 years. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm.

The Breath Powered delivery technology relies on the user's breath to propel medication into the nasal cavity where absorption is efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity while dosing. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduce GI absorption.

ONZETRA Xsail Important Safety Information
ONZETRA Xsail is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use

• Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with ONZETRA Xsail, reconsider the diagnosis of migraine before treatment of subsequent attacks with ONZETRA Xsail.
• ONZETRA Xsail is not indicated for the prevention of migraine attacks.
• Safety and effectiveness of ONZETRA Xsail have not been established for the treatment of cluster headache.

ONZETRA Xsail is contraindicated in patients with:

• Ischemic coronary artery disease (CAD) or coronary artery vasospasm, including Prinzmetal's angina; or Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
• History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; or uncontrolled hypertension
• Recent (i.e., within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-HT1 agonist; or concurrent or recent (within 2 weeks) use of a MAO-A inhibitor
• Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) or severe hepatic impairment

Other serious adverse events associated with the use of sumatriptan or 5-HT1 agonists include: myocardial ischemia/infarction, Prinzmetal's angina, arrhythmias; chest, throat, neck and/or jaw pain/tightness/pressure; cerebral hemorrhage, subarachnoid hemorrhage, and stroke; peripheral vascular ischemia, gastrointestinal vascular ischemia/infarction, and Raynaud's syndrome, medication overuse headache; serotonin syndrome; significant elevation in blood pressure; anaphylactic/anaphylactoid reactions; and seizures.

In clinical trials, the most common adverse reactions (≥ 2% and > placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.

Advise patients to carefully read the Patient Information and Instructions for Use prior to using ONZETRA Xsail.

For additional important safety information about ONZETRA Xsail, please see Full Prescribing Information or visit www.ONZETRA.com.

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.

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SOURCE Avanir Pharmaceuticals, Inc.

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