Avanir Pharmaceuticals : Announces Publication of Positive Phase IIIb Results from AVP-825 Head-to-Head COMPASS Study in the Journal "Headache"

ALISO VIEJO, Calif., June 17, 2015 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. today announced that COMPASS, its Phase IIIb, cross-over clinical trial comparing the efficacy and safety of AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraine across multiple attacks, has been published and is available in hard copy at the 57th Annual Scientific Meeting of the American Headache Society (AHS) in Washington, DC. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered™ delivery technology. A New Drug Application (NDA) for AVP-825 has been accepted and is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of November 6, 2015.

The study results showed that patients treated with AVP-825 achieved pain relief and pain freedom in significantly more migraine attacks at all time points from 15-90 minutes post-dose compared to sumatriptan tablets. AVP-825 and sumatriptan tablets achieved sustained pain relief and pain freedom at 24 and 48 hours in a similar number of attacks. In addition, AVP-825 treated patients experienced early resolution of all migraine-associated symptoms of nausea, sensitivity to sound and to light in more attacks compared with sumatriptan tablets.

"These data show that, with its novel delivery system, AVP-825 can help migraine sufferers achieve fast pain relief across more migraine attacks, at a substantially lower dose, compared with the most commonly prescribed triptan tablets," said Dr. Stewart Tepper, Professor of Medicine (Neurology), Cleveland Clinic Lerner College of Medicine. "AVP-825 has the potential to address a great unmet need for migraine sufferers who are looking for a fast-acting treatment that provides sustained relief."

"AVP-825 was designed to deliver low-dose sumatriptan deep into the nasal cavity, where it can be readily and efficiently absorbed," said Joao Siffert, MD, chief medical officer of Avanir. "Very few head-to-head studies are conducted in the migraine space and we are pleased with these positive results."

The overall safety profile of AVP-825 was consistent with that observed in previous trials. There were no serious adverse events during the study. Nasal discomfort and product taste were the most commonly reported adverse events, occurring more frequently in the AVP-825 treatment group. Nearly 90% of these reported adverse events were deemed mild and led to only one patient discontinuing treatment. Atypical sensations, sometimes called "triptan effects" were significantly less frequent among patients treated with AVP-825 compared with sumatriptan tablets (2% and 5%, respectively; p=0.02).

Percent of Migraine Attacks with Pain Relief (defined as pain level reduced to mild or none) over time:
Time-point after Administration of Study Drug	AVP-825 (n=185)	100mg Sumatriptan Tablets (n=185)	p-value
Number of attacks	509	532
Attacks with Pain Relief
At 15 minutes	27.9%	20.9%	0.007
At 30 minutes	53.8%	38.7%
At 60 minutes	72.1%	62.6%	0.001
At 90 minutes	77.4%	72.0%	0.03
At 120 minutes	79.6%	76.9%	0.21
Percent of Migraine Attacks with Pain Freedom (defined as pain level reduced to none):
Time-point after Administration of Study Drug	AVP-825 (n=185)	100mg Sumatriptan Tablets (n=185)	p-value
Number of attacks	765	766
At 15 minutes	7.2%	3.7%	0.008
At 30 minutes	18.2%	10.8%	0.001
At 60 minutes	41.2%	32.9%	0.002
At 90 minutes	52.8%	44.9%	0.006
At 120 minutes	60.4%	56.3%	0.27

Additional data related to AVP-825 will be presented at the American Headache Society, 57th Annual Scientific Meeting, June 18 - 21, 2015, Washington, DC. The following will be included in the Scientific Paper Presentations - Session 1, on June 19 from 11:30 a.m. - 1:00 p.m. ET:

• Total Migraine Freedom for Breath Powered Intranasal Delivery of 22 mg Sumatriptan Powder (AVP-825) Versus 100 mg Oral Sumatriptan from the COMPASS Study of Acute Treatment of Migraine.
• Faster Reduction in Migraine Pain Intensity at Early Time Points with AVP-825 vs. Oral Sumatriptan: Results from the COMPASS Study.
• Faster Improvement in Migraine-Related Disability at Early Time Points with AVP-825 vs. Oral Sumatriptan: Results from the COMPASS Study
• Rapid Response in Migraine Patients Treated with Breath Powered™ Intranasal Delivery of Sumatriptan Powder (AVP-825): Efficacy Analysis by Prior Triptan History from the Phase 3 TARGET Study

About the COMPASS Study
The Compass study is a multicenter, randomized, double-blind, double-dummy crossover study in which migraine sufferers were treated with either 22 mg of AVP-825 and placebo tablet or Breath Powered device-delivered placebo and 100 mg sumatriptan tablet. Study participants were instructed to treat up to five migraine attacks in each treatment period of up to 12 weeks. Migraine pain and presence of migraine associated symptoms of phonophobia (sensitivity to sound), photophobia (sensitivity to light) and nausea/vomiting were assessed immediately before dosing and at 10, 15, 30, 45, 60, 90, 120 minutes and at 24 and 48 hours after administration. 275 participants and 1531 migraines were assessed during the study.

About AVP-825
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder (22mg) delivered intranasally utilizing a novel Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine. AVP-825 is an investigational drug-device combination product not approved by the FDA. Sumatriptan is the most commonly prescribed migraine medication. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm.

The Breath Powered delivery technology is activated by user's breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. 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 deep 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 or inhalation of sumatriptan powder into the lungs.

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 13 million prescriptions written annually. Sumatriptan is the class leader with a market share of over 50% making it the most commonly prescribed migraine drug in the U.S. 100 mg tablets are the most commonly prescribed form of sumatriptan. An online survey of over 2,500 frequent migraine sufferers revealed that 66% were dissatisfied with their treatments. 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 Pharmaceutical is a leading firm in the challenging area of mental health and also has products and research programs for several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical and its affiliates employ approximately 30,000 people globally, and the company welcomes you to visit its global website at: http://www.otsuka.co.jp/en/index.php

Avanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.

©2015 Avanir Pharmaceuticals, Inc. All Rights Reserved.

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SOURCE Avanir Pharmaceuticals, Inc.