Shire Reports Findings From an Analysis Examining Emotional Lability in Children With ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII
Post hoc analysis of Phase 3 study data presented at national psychiatric meeting
PHILADELPHIA, Nov. 12 /PRNewswire-FirstCall/ -- Shire plc , the
global specialty biopharmaceutical company, announced findings from
a post hoc analysis examining emotional lability from Phase 3 study
data with Vyvanse®. In this study, Vyvanse demonstrated
significant improvement in Attention-Deficit/Hyperactivity Disorder
(ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS
IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in
children with ADHD aged 6 to 12 years. The post hoc analysis showed
that patients demonstrated an improvement in emotional lability
composite CPRS-RS scores while taking Vyvanse as compared to
placebo. These results were presented recently at a psychiatric
meeting in Honolulu.
"Children taking ADHD medications can experience emotional
lability, often described as frequent changes in emotions or mood.
Therefore, evaluating the impact of ADHD treatments, including
Vyvanse, on children's emotional lability may be important for
parents and health care professionals when assessing a child's
treatment plan," said Ann C. Childress, MD, study investigator and
president of the Center for Psychiatry and Behavioral Medicine,
Inc. in Las Vegas.
About the Analysis and Study
This post hoc analysis was based on a Phase 3, randomized,
double-blind, placebo-controlled trial with forced-dose escalation
of Vyvanse (30, 50, or 70 mg/d) or placebo in 285 children aged 6
to 12 years with ADHD. The primary end point of the study was the
ADHD-RS IV, and secondary end points included CPRS-RS and safety.
The CPRS-RS scale in its entirety contains 27 items to evaluate
children's behaviors based on parents' responses. Each of the
CPRS-RS 27 items is scored from zero as "Not At All True/Never,
Seldom" up to three as "Very Much True/Very Often, Very Frequent."
Parents completed the CPRS at 10 AM, 2 PM, and 6 PM at study start
and on the day before their children made the weekly study visits.
In the post hoc analysis, the children's emotional lability score
was determined based on the sum of their average scores from three
items on the CPRS-RS: angry/resentful, loses temper, and irritable.
Patients were then grouped into those with and without prominent
emotional lability at study start (scores greater than three versus
scores of three or less) so that each group could be evaluated
separately.
Overall, the children's average emotional lability scores
significantly improved with Vyvanse treatment compared with placebo
across the day (10 AM, 2 PM, and 6 PM) from study start to end (all
P less than or equal to .0004).
As expected, treatment with Vyvanse, compared to placebo, did
not result in significant improvements in emotional lability scores
from study start to end in those without prominent emotional
lability prior to treatment. However, treatment with Vyvanse,
compared to placebo, yielded significant improvements in the
emotional lability scores of those children with prominent
emotional lability (P<.0001).
The most common treatment-emergent adverse events reported in
this study for patients taking Vyvanse were decreased appetite,
insomnia, upper abdominal pain, headache, irritability, vomiting,
weight decrease, nausea, dizziness, and dry mouth.
Vyvanse, which was introduced in the United States in July 2007
for the treatment of ADHD in children aged 6 to 12 years and
approved in April 2008 to treat ADHD in adults, is currently
available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60
mg, and 70 mg.
Vyvanse is a therapeutically inactive prodrug stimulant, in
which d-amphetamine is covalently bonded to l-lysine, and after
oral ingestion it is converted to pharmacologically active
d-amphetamine. The conversion of Vyvanse to d-amphetamine is not
affected by gastrointestinal pH and is unlikely to be affected by
alterations in GI transit times.
Additional information about Vyvanse and Full Prescribing
Information, including the Medication Guide, are available at
http://www.vyvanse.com/.
About Vyvanse
Vyvanse is indicated for the treatment of ADHD. Efficacy based
on two controlled trials in children aged 6 to 12 and one
controlled trial in adults.
Vyvanse should not be taken by patients who have advanced
arteriosclerosis; symptomatic cardiovascular disease; moderate to
severe hypertension; hyperthyroidism; known hypersensitivity or
idiosyncrasy to sympathomimetic amines; agitated states; glaucoma;
a history of drug abuse; or during or within 14 days after
treatment with monoamine oxidase inhibitors (MAOIs).
Sudden death has been reported in association with CNS stimulant
treatment at usual doses in children and adolescents with
structural cardiac abnormalities or other serious heart problems.
Sudden death, stroke, and myocardial infarction have been reported
in adults taking stimulant drugs at usual doses in ADHD. Physicians
should take a careful patient history, including family history,
and physical exam, to assess the presence of cardiac disease.
Patients who report symptoms of cardiac disease such as exertional
chest pain and unexplained syncope should be promptly evaluated.
Use with caution in patients whose underlying medical condition
might be affected by increases in blood pressure or heart
rate.
New psychosis, mania, aggression, growth suppression, and visual
disturbances have been associated with the use of stimulants. Use
with caution in patients with a history of psychosis, seizures or
EEG abnormalities, bipolar disorder, or depression. Growth should
be monitored in children during treatment with stimulants, and
patients who are not growing (gaining height or weight) as expected
may need to have their treatment interrupted.
Amphetamines have a high potential for abuse. Administration of
amphetamines for prolonged periods of time may lead to drug
dependence. Particular attention should be paid to the possibility
of subjects obtaining amphetamines for non-therapeutic uses or
distribution to others and the drugs should be prescribed or
dispensed sparingly. Misuse of amphetamine may cause sudden death
and serious cardiovascular adverse events.
The most common adverse events reported in clinical studies of
Vyvanse were: pediatric - decreased appetite, insomnia, abdominal
pain, and irritability; adult - decreased appetite, insomnia, and
dry mouth.
About ADHD
ADHD is one of the most common psychiatric disorders in children
and adolescents. Worldwide prevalence of ADHD is estimated at 5.3
percent (with large variability), according to a comprehensive
systematic review of this topic published in 2007 in the American
Journal of Psychiatry. In the United States, approximately 7.8
percent of all school-aged children, or about 4.4 million children
aged 4 to 17 years, have been diagnosed with ADHD at some point in
their lives, according to the Centers for Disease Control and
Prevention (CDC). The disorder is also estimated to affect 4.4
percent of US adults aged 18 to 44 based on results from the
National Comorbidity Survey Replication. When this percentage is
extrapolated to the full US population aged 18 and over, almost 10
million adults are believed to have ADHD.
ADHD is a psychiatric behavioral disorder that manifests as a
persistent pattern of inattention and/or hyperactivity-impulsivity
that is more frequent and severe than is typically observed in
individuals at a comparable level of development. The specific
etiology of ADHD is unknown and there is no single diagnostic test
for this disorder. Adequate diagnosis requires the use of medical
and special psychological, educational, and social resources,
utilizing diagnostic criteria such as Diagnostic and Statistical
Manual of Mental Disorders-IV (DSM-IV®) or International
Classification of Diseases 10 (ICD-10).
Although there is no cure for ADHD, there are accepted
treatments that specifically target its symptoms. Standard
treatments include educational approaches, psychological or
behavioral modification, and/or medication.
SHIRE PLC
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire focuses its business on attention
deficit hyperactivity disorder (ADHD), human genetic therapies
(HGT) and gastrointestinal (GI) diseases as well as opportunities
in other therapeutic areas to the extent they arise through
acquisitions. Shire's in-licensing, merger and acquisition efforts
are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire believes
that a carefully selected and balanced portfolio of products with
strategically aligned and relatively small-scale sales forces will
deliver strong results.
For further information on Shire, please visit the Company's Web
site: http://www.shire.com/.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995
Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve
a number of risks and uncertainties and are subject to change at
any time. In the event such risks or uncertainties materialize, the
Company's results could be materially adversely affected. The risks
and uncertainties include, but are not limited to, risks associated
with: the inherent uncertainty of research, development, approval,
reimbursement, manufacturing and commercialization of the Company's
Specialty Pharmaceutical and Human Genetic Therapies products, as
well as the ability to secure and integrate new products for
commercialization and/or development; government regulation of the
Company's products; the Company's ability to manufacture its
products in sufficient quantities to meet demand; the impact of
competitive therapies on the Company's products; the Company's
ability to register, maintain and enforce patents and other
intellectual property rights relating to its products; the
Company's ability to obtain and maintain government and other
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with the Securities and Exchange Commission.
Source: Shire plc
CONTACT: Matthew Cabrey, Shire North America, +1-484-595-8248,
or Mindy
Huber, Porter Novelli for Shire, +1 212 601 8330, or +1 917 653
6134 (mobile)
Web Site: http://www.shire.com/
Posted: November 2009
