VYVANSE demonstrated significant improvement in ADHD symptoms in adults
WASHINGTON, May 8 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP,
Nasdaq: SHPGY), the global specialty biopharmaceutical company, today
presented the results of a phase III pivotal study in which VYVANSE
demonstrated significant improvements in Attention Deficit Hyperactivity
Disorder (ADHD) symptoms in adults and met all safety and efficacy
endpoints.
"Adults with ADHD often find it challenging to focus and organize
during the day. The disorder may impact many aspects of their lives from
career to family and personal commitments," said Lenard A. Adler, M.D.,
lead researcher in this study and director of the Adult ADHD program at the
NYU Langone Medical Center, associate professor of psychiatry, neurology
and child and adolescent psychiatry at the New York University School of
Medicine, as well as author of Scattered Minds: Help and Hope for Adults
with ADHD (G. P. Putnam's Sons 2006). "This study demonstrated that VYVANSE
significantly improved ADHD symptoms in adults, including inattention, such
as the ability to focus, organize and complete tasks, which are essential
during an adult day, as well as hyperactivity, such as restlessness, and
impulsivity."
This double-blind, placebo-controlled, four-week, forced-dose study in
414 adults aged 18 to 55 years showed that treatment with VYVANSE at all
doses studied (30 mg, 50 mg, 70 mg) provided a significant reduction in
ADHD Rating Scale (ADHD-RS-IV) scores within one week that were observed
throughout the full treatment period. At endpoint, VYVANSE demonstrated a
significant improvement in ADHD symptoms, based on a 43 percent reduction
in ADHD-RS scores. This is the largest placebo-controlled stimulant trial
of ADHD in adults conducted to date.
Additional Study Findings
Investigators also measured the efficacy of VYVANSE with the Clinical
Global Impressions-Improvement (CGI-I) scale and found that the percentage
of subjects taking VYVANSE rated "much improved" or "very much improved"
was approximately 60 percent across all doses and was significantly greater
than placebo.
The most commonly reported adverse events in this study were generally
mild to moderate in severity and included decreased appetite, insomnia and
dry mouth.
On April 23, 2008, Shire received approval from the U.S. Food and Drug
Administration (FDA) for VYVANSE for the treatment of ADHD in adults aged
18 to 55 years. The FDA approved VYVANSE for the treatment of ADHD in
children aged 6 to 12 years on February 23, 2007.
Additional information about VYVANSE and Full Prescribing Information
are available at http://www.vyvanse.com.
The study was supported by funding from Shire.
Note to Editors
ADHD-RS-IV is a standardized, validated test for assessing symptoms of
ADHD and for assessing their response to treatment. The scale, which
contains 18 items, is based on the ADHD diagnostic criteria as defined in
the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,
Text Revision(R), a publication of the American Psychiatric Association.
The CGI-I scale is a standard assessment used to rate the severity of a
patient's illness and improvement over time.
About ADHD
ADHD is one of the most common psychiatric disorders in children and
adolescents. Approximately 7.8 percent of all school-aged children, or
about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed
with ADHD at some point in their lives, according to the U.S. Centers for
Disease Control and Prevention (CDC). The disorder is also estimated to
affect 4.4 percent of U.S. adults aged 18-44 based on results from the
National Comorbidity Survey Replication, a nationally representative
household survey, which used a lay-administered diagnostic interview to
assess a wide range of DSM-IV disorders. ADHD is a neurobiological 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. To
be properly diagnosed with ADHD, a child needs to demonstrate at least six
of nine symptoms of inattention; and/or at least six of nine symptoms of
hyperactivity/impulsivity; the onset of which appears before age 7 years;
that some impairment from the symptoms is present in two or more settings
(e.g., at school and home); that the symptoms continue for at least six
months; and that there is clinically significant impairment in social,
academic or occupational functioning and the symptoms cannot be better
explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments
that specifically target its symptoms. The most common standard treatments
include educational approaches, psychological or behavioral modification,
and medication.
About VYVANSE
Tell the doctor about any heart conditions, including structural
abnormalities, that you, your child, or a family member, may have. Inform
the doctor immediately if you or your child develops symptoms that suggest
heart problems, such as chest pain or fainting.
Vyvanse should not be taken if you or your child has advanced disease
of the blood vessels (arteriosclerosis); symptomatic heart disease;
moderate to severe high blood pressure; overactive thyroid gland
(hyperthyroidism); known allergy or unusual reactions to drugs called
sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma;
a history of problems with alcohol or drugs; agitated states; taken a
monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell the doctor before taking Vyvanse if you or your child is being
treated for or has symptoms of depression (sadness, worthlessness, or
hopelessness) or bipolar disorder; has abnormal thought or visions, hears
abnormal sounds, or has been diagnosed with psychosis; has had seizures or
abnormal EEGs; has or has had high blood pressure; exhibits aggressive
behavior or hostility. Tell the doctor immediately if you or your child
develops any of these conditions or symptoms while taking Vyvanse.
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events. These events
have also been reported rarely with amphetamine use.
Vyvanse was generally well tolerated in clinical studies. The most
common side effects reported in studies of Vyvanse were: children --
decreased appetite, difficulty falling asleep, stomachache, and
irritability; adult -- decreased appetite, difficulty falling asleep, and
dry mouth.
Aggression, new abnormal thoughts/behaviors, mania, growth suppression,
worsening of motion or verbal tics, and Tourette's syndrome have been
associated with use of drugs of this type. Tell the doctor if you or your
child has blurred vision while taking Vyvanse.
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 and
hyperactivity disorder (ADHD), human genetic therapies (HGT),
gastrointestinal (GI) and renal diseases. The structure is sufficiently
flexible to allow Shire to target new therapeutic areas to the extent
opportunities arise through acquisitions. Shire's in-licensing, merger and
acquisition efforts are focused on products in niche markets with strong
intellectual property protection either in the US or Europe. Shire believes
that a carefully selected 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 website:
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, Shire's results could be
materially affected. The risks and uncertainties include, but are not
limited to, risks associated with: the inherent uncertainty of
pharmaceutical research, product development including, but not limited to
the successful development of JUVISTA(R) (Human TGF(beta)3) and
velaglucerase alfa (GA-GCB); manufacturing and commercialization including,
but not limited to, the establishment in the market of VYVANSE(TM)
(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder
("ADHD")); the impact of competitive products, including, but not limited
to, the impact of those on Shire's ADHD franchise; patents, including but
not limited to, legal challenges relating to Shire's ADHD franchise;
government regulation and approval, including but not limited to the
expected product approval date of INTUNIV(TM) (guanfacine extended release)
(ADHD); Shire's ability to secure new products for commercialization and/or
development; and other risks and uncertainties detailed from time to time
in Shire plc's filings with the Securities and Exchange Commission,
including Shire plc's Annual Report on Form 10-K for the year ended
December 31, 2007.
SOURCE Shire plc
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