Avanir Pharmaceuticals Announces Positive Outcome of Phase IIIb COMPASS Trial: A Head-to-Head Study Comparing AVP-825 to Oral Sumatriptan for the Acute Treatment of Migraine
The COMPASS study met the primary endpoint for the sum of pain intensity difference at 30 minutes post dose (SPID30), showing that migraine sufferers achieved greater pain relief within 30 minutes of treatment with 22 mg of the investigational product AVP-825 compared with 100 mg sumatriptan tablet (p<0.0001). In addition, AVP-825 treated migraine sufferers achieved pain freedom in a greater proportion of migraine attacks at 15, 30, 45, 60 and 90 minutes post dose compared with those treated with sumatriptan tablet (p<0.05). In these topline data, several additional secondary endpoints relating to pain relief were also met.
The overall safety profile of AVP-825, an investigational product, was consistent with that observed in previous trials, with less than 2% of subjects experiencing an adverse event leading to treatment discontinuation. There were no serious adverse events in the study. Nasal discomfort and abnormal product taste were more common with AVP-825 administration; these adverse events were deemed mild in nearly 90% of cases.
Avanir plans to review the detailed data from the COMPASS study and present the full results at an upcoming medical meeting.
"There are millions of Americans suffering from migraine who are dissatisfied with their current treatment options," said
"AVP-825 was designed to deliver sumatriptan powder deep into the nasal cavity where is can be readily and efficiently absorbed," said
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 the investigational drug-device combination product AVP-825 and placebo tablet or Breath Powered device-delivered placebo and 100 mg sumatriptan tablets. Study participants were instructed to treat up 5 migraine attacks in each 12-week treatment period. Migraine headache 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.
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
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 than through most other routes. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely. 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.
Migraine represents an area of significant unmet medical need. According to the
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Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements relating to the potential effectiveness and/or safety of AVP-825, the timing for an
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