Avanir Pharmaceuticals to Present Data on ONZETRA™ Xsail™ at American Headache Society (AHS) 2016 Annual Scientific Meeting

ALISO VIEJO, Calif., June 9, 2016 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. today announced that the company will be presenting results from several studies about ONZETRA™ Xsail™ (sumatriptan nasal powder) 11 mg per nose piece, formerly AVP-825, at the 58th American Headache Society Annual Scientific Meeting being held in San Diego from June 9-12, 2016. ONZETRA Xsail was approved by the U.S. Food and Drug Administration (FDA) in January 2016 and is now available for prescription for the acute treatment of migraine with or without aura in adults.

"We are excited to present data about ONZETRA Xsail at this year's AHS Annual Meeting as these results will provide additional information to help healthcare professionals and patients determine the best treatment for migraine, an area with significant unmet need," said Rohan Palekar, president and CEO of Avanir. "We believe that ONZETRA Xsail—which delivers a fast-acting dry powder dosage of a leading migraine treatment in the first Breath Powered^® intranasal delivery system—addresses one of the greatest challenges faced by migraine sufferers: obtaining rapid relief with a known side effect profile."

Two key Avanir poster presentations that will highlight key pharmacokinetic and additional safety data for ONZETRA Xsail include:

• "Pharmacokinetic Modeling Study to Evaluate Two Intranasal Formulations of Sumatriptan for Nasal vs Gastrointestinal Tract Absorption" to be presented as a late-breaker by Dr. Laura Pope and Dr. Kenneth Schulman of Avanir Pharmaceuticals on Saturday, June 11 from 1:15-2:30 pm PT in the San Diego Ballroom (North Tower Lobby Level). Late Breaker Poster.
• "Characterizing the Most Common AEs Following Treatment with AVP-825: Exploring Abnormal Taste and Nasal Discomfort across Multiple Attacks in COMPASS Study" to be presented by Dr. James S. McGinley of Vector Psychometric Group on Friday, June 10 from 1:15-2:30 pm PT in the San Diego Ballroom (North Tower Lobby Level). Poster F13. 

Additional poster presentations for ONZETRA Xsail at AHS 2016 include:

• "Reduced Treatment-Emergent Nausea Using AVP-825 vs. Sumatriptan Tablets: A Comparative Effectiveness Study" to be presented by Dr. Kenneth Shulman of Avanir Pharmaceuticals on Friday, June 10 from 1:15-2:30 pm PT in the San Diego Ballroom (North Tower Lobby Level). Poster F15.
• "AVP-825 Reduces Nausea Faster Than Sumatriptan Tablets: A Comparative Effectiveness Study" to be presented by Dr. James McGinley of Vector Psychometric Group on Friday, June 10 from 1:15-2:30 pm PT in the San Diego Ballroom (North Tower Lobby Level). Poster F14.
• "Faster Migraine Relief Using AVP-825 Compared with Sumatriptan Tablet: Using a Latent Variable Perspective" to be presented by Dr. Richard Lipton of Albert Einstein College of Medicine on Friday, June 10 from 1:15-2:30 pm PT in the San Diego Ballroom (North Tower Lobby Level). Poster F16.
• "A Low Incidence of Atypical Sensations with AVP-825 (Breath Powered Intranasal Delivery System Containing 22 Mg Sumatriptan Powder) Migraine Therapy Across Multiple Phase 2/3 Clinical Trials" to be presented by Dr. Stewart Tepper of Geisel School of Medicine at Dartmouth on Friday, June 10 from 1:15-2:30 pm PT in the San Diego Ballroom (North Tower Lobby Level). Poster F11. 

Avanir Pharmaceuticals will be exhibiting at the meeting in Booth #207.

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 Migraine

Migraine represents an area of significant unmet medical need. According to the Centers for Disease Control and Prevention, over 37 million Americans suffer from migraine headaches. The triptan class of medications is generally considered the standard of care with over 14 million prescriptions written annually. Sumatriptan is the class leader with a market share of over 50 percent, making it the most commonly prescribed migraine drug in the U.S., and 100 mg tablets are the most commonly prescribed form of sumatriptan. In a published survey of 688 migraine sufferers, 71 percent were found to be not fully satisfied with their migraine treatment.¹ As a result, many migraine sufferers are seeking new, fast-acting, well-tolerated treatment options.

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 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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¹Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39(suppl 2):S20-S26.

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SOURCE Avanir Pharmaceuticals, Inc.

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