AVANIR Pharmaceuticals Announces U.S. Launch and Availability of ONZETRA™ Xsail™ for the Acute Treatment of Migraine in Adults

ALISO VIEJO, Calif., May 16, 2016 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. today announced ONZETRA™ Xsail™ (sumatriptan nasal powder) is now available by prescription in U.S. pharmacies.

The U.S. Food and Drug Administration (FDA) approved ONZETRA Xsail in January 2016 for the acute treatment of migraine with or without aura in adults. The approval was based on data from phase II and phase III trials, safety data from more than 300 patients and reference data from the extensive clinical use of sumatriptan over the past 20 years.

ONZETRA Xsail provides a fast-acting, 22mg dose, dry powder formulation of sumatriptan, the most commonly prescribed migraine medication, administered via the first Breath Powered intranasal medication delivery system for the acute treatment of migraine. The Xsail Breath Powered Delivery Device allows the medication to be deposited into the nose, an area that is rich with blood vessels, providing targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat.

"Due to gastric stasis and nausea which often occurs during a migraine, non-oral treatments are an excellent option to consider for most migraine patients," said Stewart Tepper, M.D., professor of neurology at Geisel School of Medicine at Dartmouth. "Oral sumatriptan may be poorly absorbed, which can lead to slow onset of effect, sometimes with a relatively poor tolerability profile. Being able to deliver sumatriptan powder deep in the superior nasal cavity goes a long way to mitigate many of these issues."

"Making our second product available to patients is an important milestone for Avanir," said Rohan Palekar, president and CEO of Avanir. "The launch of ONZETRA is further evidence of our commitment to bringing innovative medicines to patients with central nervous system disorders of high unmet medical need."

Avanir's existing specialty sales force will call on neurologists and primary care clinics for ONZETRA.

AVANIR is committed to assisting patients who experience migraines in accessing coverage for ONZETRA Xsail. To support the availability of ONZETRA Xsail, Avanir provides patient support services, including a reimbursement counseling hotline to help people who suffer from migraines navigate potential administrative insurance issues and a co-pay assistance program to reduce out-of-pocket costs for eligible patients. For more information about ONZETRA Xsail and the patient support services, please visit www.ONZETRA.com or call 844-ONZETRA.

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.

DJE Science Media Contact
Jessica Donnelly
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+1 (323) 202-1051

¹ Lipton 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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