Avanir Pharmaceuticals Announces Publication of Pivotal Phase III Results from AVP-825 Acute Migraine Study in the Journal "Headache"
"Some studies indicate that nearly half of the 37 million Americans suffering from migraines are dissatisfied with their current treatment. We believe AVP-825 could provide a targeted, fast acting migraine treatment option by combining low-dose sumatriptan, the most widely used prescription migraine medication, with an innovative delivery method," said
About the Phase III TARGET Study
In this multicenter, double-blind, placebo-controlled study, 230 migraine sufferers were randomized to self-administer either AVP-825 or placebo using the Breath Powered device when they had moderate to severe migraine pain. Pain scores were then assessed at various time points after administration. Pain was evaluated using a four point scale with headache relief defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or complete relief (grade 0).
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 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.
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 and the most commonly prescribed migraine drug in the U.S. with a market share of over 50% making 100 mg tablets the most commonly prescribed form of sumatriptan. In a recent study, over 40 percent of migraine patients reported that they were not satisfied with their current medication and that 80 percent are willing to try another medication.
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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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