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
BrewLife Media Contact
Kelly
France, PhD
kfrance@brewlife.com
+1 (415) 946-1076
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SOURCE Avanir Pharmaceuticals, Inc.