ALISO VIEJO, Calif.,
July 23, 2015 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. today announced new
findings from the dementia/Alzheimer's disease cohort of the PRISM
II study, a phase IV study evaluating the safety and effectiveness
of NUEDEXTA® in treating pseudobulbar affect (PBA) in patients with
dementia/Alzheimer's disease, stroke and traumatic brain injury
(TBI). PBA is a distressing condition characterized by sudden and
uncontrollable outbursts of laughing and/or crying resulting from
certain neurologic diseases or brain injury. The data were
presented at the 2015 Alzheimer's Association International
Conference (AAIC) in Washington,
D.C., along with two additional presentations related to
Avanir's program in agitation secondary to Alzheimer's disease.
"PBA is often treated with antidepressants, so we wanted to
analyze the differential effects of NUEDEXTA based on concomitant
antidepressant usage in patients with PBA secondary to
dementia/Alzheimer's disease who enrolled in the PRISM II study,"
said Joao Siffert, M.D., executive
vice president, R&D, and chief medical officer at Avanir. "In
the study, the treatment benefit with NUEDEXTA on PBA symptoms was
the same whether or not the patient was on antidepressants when
they enrolled in the study."
New Data Demonstrate Treatment Effects on PBA with
Dextromethorphan/Quinidine Regardless of Concomitant Antidepressant
Use in Dementia/Alzheimer's Disease Cohort of PRISM II
Study
New post-hoc analysis analyzed the differential effects on PBA
of NUEDEXTA based on concomitant antidepressant usage in patients
with PBA secondary to dementia/Alzheimer's disease. At baseline, 76
patients (57.0%) were receiving concomitant antidepressants.
Improvements in mean Center for Neurologic Study-Lability Scale
(CNS-LS) score at final visit vs. baseline and PBA episode count
were significant (P<0.001 for all) irrespective of
antidepressant use. Similar percentages of antidepressant users vs.
non-users were rated "much"/"very much" improved on Patient Global
Impression of Change (PGI-C;74.1% vs. 79.5%) and Clinician Global
Impression of Change (CGI-C;74.1% vs. 81.8%). Adverse events (AEs)
occurred in 28 (36.8%) concomitant antidepressant users vs. 21
(36.2%) non-users. The most common AEs were headache (7.9% vs.
6.9%), urinary tract infection (2.6% vs. 6.9%), and diarrhea (2.6%
vs 5.2%).
Presentation Details:
Title:
Dextromethorphan/Quinidine for Treatment of Pseudobulbar Affect in
Patients with Dementia: Treatment Effects by Concomitant
Antidepressant Use in a 12-week Open-Label Trial (PRISM II)
Presentation Number: 04-09-06
Time: Wednesday, July 22,
4:15 p.m. ET
New Data Demonstrate Minimal Difference Between
Patient-Reported and Caregiver Reported Outcomes in
Dementia/Alzheimer's Disease Cohort of PRISM II Study
New post-hoc analysis from the dementia/Alzheimer's disease
cohort of the PRISM II study compared patient-completed and
caregiver-completed ratings for all effectiveness measures that
were consistently completed by the same reporter at all
time-points. Caregiver-proxy vs. patient-completed ratings did not
differ significantly across these measures, except for PBA episode
counts. The difference in the patient and caregiver reports for
this measure could potentially be related to the patient's memory
deficits, lack of awareness, or both.
Poster Presentation Details:
Title:
Dextromethorphan/Quinidine for Treatment of Pseudobulbar Affect in
Patients With Dementia: Comparison of Patient-Reported Ratings to
Those of Caregiver Proxies in a 12-Week Open-Label Trial (PRISM
II)
Poster Number: P1-300
Time: Sunday, July 19, 9:30 a.m. – 4:15p.m.
ET
Dextromethorphan/Quinidine Significantly Improved PBA
Symptoms of Both Uncontrollable Laughing and Crying in
Dementia/Alzheimer's Disease Cohort of PRISM II Study
Additional analysis of the CNS-LS and individual CNS-LS Item
Scores showed that NUEDEXTA significantly improved PBA symptoms of
both uncontrollable laughing and uncontrollable crying. In
addition, despite open-label limitations of the study, reduction in
CNS-LS was similar to that in the NUEDEXTA phase III pivotal trial
in patients with PBA secondary to ALS or MS.
Poster Presentation Details:
Title:
Dextromethorphan/Quinidine for Treatment of Pseudobulbar Affect in
Patients With Dementia: Examination of CNS-LS Outcomes in a 12-Week
Open-Label Trial (PRISM II)
Poster Number: P3-290
Time: Tuesday, July 21, 9:30 a.m. – 4:15 p.m. ET
About PRISM II
PRISM II is a phase IV study that
evaluated the safety, tolerability and effectiveness of NUEDEXTA
capsules containing 20 mg dextromethorphan hydrobromide (DM) and 10
mg quinidine sulfate (Q) for treatment of PBA in patients with
Alzheimer's disease and other dementias, stroke and traumatic brain
injury.
PRISM II is a nationwide, open-label, multicenter study that
enrolled 367 patients at approximately 100 study centers. Eligible
patients were age ≥18 years with a clinical diagnosis of PBA and
baseline score ≥13 on the CNS-LS. Patients with TBI due to a
penetrating head injury were excluded. Patients were treated with
NUEDEXTA twice daily for 12 weeks. The primary endpoint was change
from baseline in PBA symptoms as measured by the CNS-LS, an
instrument originally validated as a measure of PBA episode
frequency and severity in patients with amyotrophic lateral
sclerosis (ALS) and multiple sclerosis (MS). Determination of
effectiveness was based on a comparison of CNS-LS change in PRISM
II with that seen for NUEDEXTA and placebo in a previous pivotal
phase III study. Additional outcomes measures included number of
weekly PBA episodes (laughing and/or crying); Mini-Mental State
Examination; PBA impact on quality of life; CGIC; PGIC; patients'
satisfaction with treatment; Patient Health Questionnaire (PHQ-9;
to evaluate mood symptoms), and a functional measure consisting of
the Neurobehavioral Functioning Inventory for patients with TBI and
Stroke Impact Scale for patients with stroke. Safety measures
included monitoring of adverse events, concomitant medication
usage, and vital signs.
About PBA
PBA is a neurologic condition characterized
by uncontrollable, disruptive laughing and/or crying outbursts that
are often contrary or exaggerated to the patient's inner mood
state. PBA occurs secondary to a variety of neurologic conditions
such as traumatic brain injury (TBI), multiple sclerosis (MS),
amyotrophic lateral sclerosis (ALS), Parkinson's disease, stroke
and Alzheimer's disease. When these disorders damage areas of the
brain that regulate normal emotional expression, they can lead to
uncontrollable, disruptive episodes of crying or laughing. For more
information about PBA, please visit www.PBAFacts.com.
About NUEDEXTA
NUEDEXTA is an innovative combination
of two well-characterized components, dextromethorphan
hydrobromide, the ingredient active in the central nervous system,
and quinidine sulfate, a metabolic inhibitor enabling therapeutic
dextromethorphan concentrations. Dextromethorphan acts on sigma-1
and NMDA receptors in the brain, although the mechanism by which
NUEDEXTA exerts therapeutic effects in patients with PBA is
unknown.
NUEDEXTA 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 (dextromethorphan hydrobromide and quinidine sulfate)
20mg/10mg capsules can interact with other medications causing
significant changes in blood levels of those medications and/or
NUEDEXTA which may lead to serious side effects. Adjust dose or use
alternate treatment of the other medication when clinically
indicated.
NUEDEXTA is contraindicated in patients concomitantly taking:
QT-prolonging drugs metabolized by CYP2D6 (e.g., thioridazine and
pimozide); monoamine oxidase inhibitors (MAOIs) within the
preceding or following 14 days; other drugs containing quinidine,
quinine, or mefloquine and in patients with a known
hypersensitivity to these drugs or any of NUEDEXTA's
components.
Discontinue use of NUEDEXTA if hepatitis, thrombocytopenia,
serotonin syndrome or a hypersensitivity reaction occurs.
NUEDEXTA is contraindicated in patients with certain risk
factors for arrhythmia: Prolonged QT interval; congenital long QT
syndrome, history suggestive of torsades de pointes; heart failure;
complete atrioventricular (AV) block or risk of AV block without an
implanted pacemaker.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating
NUEDEXTA in patients at risk for QT prolongation and torsades de
pointes, electrocardiographic (ECG) evaluation should be conducted
at baseline and 3-4 hours after the first dose. Risk factors
include left ventricular hypertrophy or dystrophy or concomitant
use of drugs that prolong QT interval or certain CYP3A4
inhibitors.
The most common adverse reactions are diarrhea, dizziness,
cough, vomiting, asthenia, peripheral edema, urinary tract
infection, influenza, increased gamma-glutamyltransferase, and
flatulence. NUEDEXTA may cause dizziness. Precautions to reduce the
risk of falls should be taken, particularly for patients with motor
impairment affecting gait or a history of falls.
These are not all the risks from use of NUEDEXTA®. Please refer
to the accompanying full Prescribing Information or visit
www.NUEDEXTA.com.
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.
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SOURCE Avanir Pharmaceuticals, Inc.