ALISO VIEJO, Calif., June 24, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that data related to the safety and efficacy of AVP-825, a Breath-Powered™ Nasal Delivery of Powdered Sumatriptan for the acute treatment of migraine, will be presented at the American Headache Society's 56 th Annual Scientific Meeting. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath-Powered™ delivery technology.
American Headache Society, 56 th Annual Scientific Meeting, June 26 – 29, 2014, Los Angeles
- A Randomized, Double-Blind, Double-Dummy, Active-Comparator Crossover Study of Breath-Powered Nasal Delivery of Sumatriptan Powder (AVP-825) in the Treatment of Acute Migraine (The COMPASS Study)
- Session: LBP-37 - Poster Session II
- Time: June 28 at 12:30 p.m. PDT
- Breath-Powered Nasal Delivery of Powdered Sumatriptan (AVP-825): Migraine Disability and Functional Outcome in a Phase 3 Study (TARGET)
- Session: P42 - Poster Session I
- Time: June 27 at 1:00 p.m. PDT
- Breath-Powered Nasal Delivery of Sumatriptan Powder (AVP-825): An Exploratory Analysis of Response in Migraine Patients Grouped by Baseline Headache Intensity from the Phase 3 TARGET Study
- Session: P43 - Poster Session II
- Time: June 28 at 12:30 p.m. PDT
About AVP-825AVP-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. In the phase III (TARGET) clinical trial the most common AEs (incidence >5%) reported for AVP-825 were product taste (22%), nasal discomfort (13%), and rhinitis (6%); local AEs were almost exclusively mild to moderate in severity and transient. 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 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.
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