ALISO VIEJO, Calif., April 15, 2015 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. today announced that data highlighting its central nervous system (CNS) therapeutics franchise, including data from the Phase 2 study of AVP-923 for the treatment of agitation in Alzheimer’s disease, data from the Alzheimer’s cohort of PRISM II of NUEDEXTA® for the treatment of Pseudobulbar Affect (PBA) and several data presentations on the use of AVP-825 for the treatment of acute migraine, will be presented at the American Academy of Neurology (AAN) Annual Meeting being held at the Walter E. Washington Convention Center in Washington, D.C., April 18-25, 2015.
AVP-923 Platform Presentation Details
Title: Dextromethorphan/Quinidine (AVP-923) Efficacy and Safety for Treatment of Agitation in Persons With Alzheimer’s
Disease: Results From a Phase 2 Study (NCT01584440)
Poster Number: S16.007
Presentation Date/Time: Tuesday, April 21, 2015; 4:45 p.m. ET
PRISM II Poster Presentation Details
Title: PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and Effectiveness of Dextromethorphan 20
mg/Quinidine 10 mg for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Results from the Alzheimer’s Disease/Dementia Cohort Poster Number: P7.109
Presentation Date/Time: Thursday, April 23, 2015; 2:00 p.m. – 6:30 p.m. ET
AVP-825 Platform Presentation Details
Title: Consistency of Response in the COMPASS Study [Breath Powered™ Nasal Delivery of 22 mg Sumatriptan Powder
(AVP-825) Versus 100 mg Oral Sumatriptan in Acute Migraine: A Comparative Clinical Trial]
Poster Number: S23.001
Presentation Date/Time: Wednesday, April 22, 2015; 2:00 p.m. ET
Title: Primary Efficacy Outcomes from COMPASS: A Comparison of Breath Powered™ Device Containing 22 mg
Sumatriptan Powder (AVP-825) Versus 100 mg Oral Sumatriptan in Acute Treatment of Migraine
Poster Number: S23.003
Presentation Date/Time: Wednesday, April 22, 2015; 2:30 p.m. ET
AVP-825 Poster Presentation Details
Title: Breath Powered™ Nasal Delivery of 22 mg Sumatriptan Powder (AVP-825): An Exploratory Analysis of Response in Migraine Patients Grouped by Baseline Headache Intensity from the Phase 3 TARGET Study Poster Number: P3.047
Presentation Date/Time: Tuesday, April 21, 2015; 2:00 p.m. – 6:30 p.m. ET
Title: Secondary Efficacy Outcomes from COMPASS: A Comparison of Breath Powered™ Device Containing 22 mg
Sumatriptan Powder (AVP-825) Versus Oral 100 mg Sumatriptan in Episodic Migraine
Poster Number: P3.047
Presentation Date/Time: Tuesday, April 21, 2015; 2:00 p.m. – 6:30 p.m. ET
Title: Pooled Analyses of Randomized, Double-Blind, Placebo-Controlled Studies of A Breath Powered™ Nasal Delivery
Device Containing 22 mg Sumatriptan Powder (AVP-825) in the Treatment of Episodic Migraine
Poster Number: P1.315
Presentation Date/Time: Monday, April 20, 2015; 2:00 p.m. – 6:30 p.m. ET
Title: Breath-Powered™ Nasal Delivery of 22 mg Powdered Sumatriptan (AVP-825): Migraine Disability and Functional
Outcome in a Phase 3 Study (TARGET)
Poster Number: P1.300
Presentation Date/Time: Monday, April 20, 2015; 2:00 p.m. – 6:30 p.m. ET
About AVP-923
AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin transporter (SERT) and norepinephrine (NET) transporter) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is an investigational drug not approved by the FDA.
About NUEDEXTA
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA is an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin transporter (SERT) and norepinephrine (NET) transporter, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.
NUEDEXTA Indication and Important Safety Information NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.
NUEDEXTA and certain other medicines can interact, causing serious side effects. If you take certain drugs or have certain heart problems, NUEDEXTA may not be right for you.
Some people can have an allergic reaction to NUEDEXTA. Call your doctor right away if you experience lightheadedness, chills, fever, nausea, or vomiting while taking NUEDEXTA.
NUEDEXTA may cause serious side effects, including changes in heart rhythm (QTc prolongation). Tell your doctor if you or a family member has or ever had any heart disease or problems. If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA. If you feel faint or lose consciousness, call your doctor right away.
NUEDEXTA may make you dizzy. Be extra careful not to fall, especially if you have a hard time walking or a problem with falling.
The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, feeling like you have the flu, abnormal liver tests, and gas. These side effects were seen in 13% or less of patients taking NUEDEXTA. Those are not all the possible risks of NUEDEXTA. Tell your doctor about any side effect that bothers you or does not go away.
These are not all the risks from use of NUEDEXTA. Please refer to full Prescribing Information at www.NUEDEXTA.com.
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 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.
Avanir Media Contact
Ian Clements, PhD
media.relations@avanir.com
+1 (949) 389-6700
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+1 (415) 946-1076
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