PHILADELPHIA, May 17, 2013 /PRNewswire/ --
Research explores data on
treatments for psychiatric disorders; health economics and outcomes
research also to be presented
Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty
biopharmaceutical company, announces that it will present
scientific data in 7 poster presentations at the American
Psychiatric Association (APA) 166th Annual Meeting in San Francisco, May
18-22. The data being presented represent Shire's ongoing
commitment to the clinical research of Vyvanse®
(lisdexamfetamine dimesylate) Capsules, (CII) and INTUNIV®
(guanfacine) Extended-Release Tablets, its approved prescription
medicines for Attention-Deficit/Hyperactivity Disorder (ADHD).
Data being presented include post-hoc analyses from several of its
phase 2 clinical studies investigating potential new psychiatric
uses of Vyvanse for the adjunctive treatment for Major Depressive
Disorder (MDD) and for the treatment of Binge Eating Disorder
(BED). Shire also will present health economic data on INTUNIV and
outcomes research in ADHD. Vyvanse and INTUNIV should only be used
to treat ADHD.
"Shire is committed to research in the field of neuroscience and
developing treatment options for conditions that have significant
unmet patient need, such as MDD and BED," said Arnaud Partiot, MD,
PhD, Shire senior vice president, Research and Development.
Vyvanse is a once-daily prescription medication for patients
ages 6 and above with Attention-Deficit/Hyperactivity disorder
(ADHD) and may be used as part of a total treatment program that
may include counseling or other therapies.
Vyvanse is a Schedule II controlled substance. CNS stimulants
(amphetamines and methylphenidate-containing
products) have a high potential for abuse and dependence. Assess
the risk of abuse prior to prescribing and
monitor for signs of abuse and dependence.
INTUNIV is indicated for the treatment of ADHD as monotherapy
and as adjunctive therapy to stimulant medications in children and
adolescents ages 6 to 17. The effectiveness of INTUNIV for more
than 8 weeks has not been systematically evaluated. The physician
electing to use INTUNIV for extended periods should periodically
reevaluate its long-term usefulness for the individual patient.
Patients with a history of hypersensitivity to INTUNIV, its
inactive ingredients, or other products containing guanfacine
should not take INTUNIV. Hypotension, bradycardia, and syncope were
observed in clinical trials. Somnolence and sedation were commonly
reported adverse reactions in clinical studies.
The titles, dates, and times of the APA scientific presentations
are noted below. Specific information about the data contained in
these scientific presentations is embargoed until the respective
presentation sessions have occurred at the meeting.
Lisdexamfetamine Dimesylate
(Investigational New Uses)
- Sunday, May 19, 2013;
8:00am - 9:30am
Poster #NR4-25: "Lisdexamfetamine Dimesylate Safety and Efficacy
on Binge Eating Days/Episodes and Behavior in Adults With Moderate
to Severe Binge Eating Disorder"
Presenter: Susan McElroy, MD
- Monday, May 20, 2013;
2:00pm - 4:00pm
Poster #NR9-20: "Effects of Lisdexamfetamine Dimesylate
Augmentation on Sexual Function in Adults With Fully or Partially
Remitted Major Depressive Disorder"
Presenter: Anita Clayton, MD
- Monday, May 20, 2013;
2:00pm - 4:00pm
Poster #NR9-41: "Response to Lisdexamfetamine Dimesylate
Augmentation in Major Depression in People With or Without Baseline
Executive Function Impairment"
Presenter: Andrew Cutler, MD
- Monday, May 20, 2013;
2:00pm - 4:00pm
Poster #NR9-30: "Lisdexamfetamine Dimesylate Augmentation
Therapy in Anxious or Nonanxious Major Depressive Disorder"
Presenter: Bryan Dirks, MD
- Monday, May 20, 2013;
2:00pm - 4:00pm
Poster #NR9-38: "Post Hoc Analysis of Lisdexamfetamine
Dimesylate Augmentation Therapy Effects on Sleep-Related Endpoints
in Adults With Major Depressive Disorder"
Presenter: Angelo Sambunaris,
MD
Guanfacine Extended Release (Health
Economics and Outcomes Research)
- Monday, May 20, 2013;
11:30pm - 1:00pm
Poster #NR8-51: "Period Prevalence of Stimulant Augmentation
Among Adolescents With ADHD in a U.S. Managed Care Population
During 2009 and 2010"
Presenter: Vanja Sikirica,
PharmD, MPH
ADHD Outcomes Research
- Monday, May 20, 2013;
11:30am - 1:00pm
Poster #NR8-29: "Long-Term Outcomes in
Attention-Deficit/Hyperactivity Disorder (ADHD): A Systematic
Review of Self Esteem and Social Functioning"
Presenter: Paul Hodgkins, PhD
ABOUT VYVANSE (lisdexamfetamine
dimesylate)
Vyvanse, which was introduced in the
United States in July 2007 for
the treatment of ADHD in children ages 6 to 12 years, approved in
April 2008 to treat ADHD in adults,
approved in November 2010 to treat
ADHD in adolescents ages 13 to 17, approved in January 2012 for maintenance treatment in adults,
and approved in April 2013 for
maintenance treatment in children and adolescents, is currently
available in the USA in six
once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg,
and 70 mg. In addition to being available in the USA and Canada, Vyvanse is approved in Brazil (brand name Venvanse), Ireland (brand name Tyvense), and Denmark, Germany, Norway, and the United Kingdom (brand name Elvanse). The
efficacy and tolerability of Vyvanse have been studied in clinical
trials in both the USA and
Europe.
Vyvanse may be used as part of a total treatment program that
may include counseling or other therapies.
INDICATION
Vyvanse is indicated for the treatment of ADHD in patients ages
6 and above. Efficacy was established in short-term controlled
studies in children aged 6 to 17 and in adults. Vyvanse is also
approved as a maintenance treatment for patients ages 6 and above
with ADHD based on one maintenance study in patients aged 6 to 17
and one maintenance study in adults.
IMPORTANT SAFETY INFORMATION
WARNING: ABUSE AND DEPENDENCE
- CNS stimulants (amphetamines and methylphenidate-containing
products) have a high potential for abuse and dependence.
Assess the risk of abuse prior to prescribing and monitor for
signs of abuse and dependence while on therapy.
Contraindications:
- Known hypersensitivity to amphetamines or other ingredients in
Vyvanse. Anaphylactic reactions, Stevens - Johnson syndrome, angioedema, and
urticaria have been observed in postmarketing reports.
- Concurrent administration of monoamine oxidase inhibitors
(MAOI) or administration of Vyvanse within 14 days of the last MAOI
dose. Hypertensive crisis can occur.
- Educate patients about abuse and periodically re-evaluate the
need for Vyvanse.
- Sudden death, stroke and myocardial infarction have been
reported in adults with CNS stimulant treatment at recommended
doses. Sudden death has been reported in children and adolescents
with structural cardiac abnormalities and other serious heart
problems taking CNS stimulants at recommended doses for ADHD. Prior
to treatment assess for the presence of cardiac disease. Avoid use
in patients with known structural cardiac abnormalities,
cardiomyopathy, serious heart arrhythmia, coronary artery disease,
and other serious heart problems. Further evaluate patients who
develop exertional chest pain, unexplained syncope, or arrhythmias
during Vyvanse treatment.
- CNS stimulants cause an increase in blood pressure (mean
increase about 2-4 mm Hg) and heart rate (mean increase about 3-6
bpm). Monitor all patients for tachycardia and hypertension.
- Use of stimulants may cause psychotic or manic symptoms in
patients with no prior history, or exacerbation of symptoms in
patients with preexisting psychosis. Clinical evaluation for
bipolar disorder is recommended prior to stimulant use.
- CNS stimulants have been associated with weight loss and
slowing of growth rate in pediatric patients. Monitor weight and
height in children during treatment with Vyvanse. Treatment may
need to be interrupted in children not growing as expected.
- The most common adverse reactions (≥5% and at least twice the
rate of placebo) reported in clinical trials were:
- Children aged 6 to 12: decreased appetite, insomnia, upper
abdominal pain, irritability, vomiting, decreased weight, nausea,
dry mouth and dizziness;
- Adolescents aged 13 to 17: decreased appetite, insomnia, and
decreased weight;
- Adults: decreased appetite, insomnia, dry mouth, diarrhea,
nausea, anxiety and anorexia.
Please click here for Full Prescribing
Information for Vyvanse,
including Boxed WARNING regarding Potential for Abuse and
Dependence.
ABOUT INTUNIV (guanfacine)
Once-daily INTUNIV is available in four doses-1 mg, 2 mg, 3 mg,
and 4 mg. The active ingredient in INTUNIV is guanfacine. INTUNIV
is not a central nervous system (CNS) stimulant or a controlled
substance, and has no known potential for abuse or dependence.
INTUNIV is a selective alpha-2A agonist. The mechanism of action of
guanfacine in ADHD is not known.
INDICATION
- INTUNIV is indicated for the treatment of ADHD as monotherapy
and as adjunctive therapy to stimulant medications in children and
adolescents ages 6 to 17. The effectiveness of INTUNIV for more
than 8 weeks has not been systematically evaluated. The physician
electing to use INTUNIV for extended periods should periodically
reevaluate its long-term usefulness for the individual
patient.
IMPORTANT SAFETY INFORMATION
- Patients with a history of hypersensitivity to INTUNIV, its
inactive ingredients, or other products containing guanfacine
should not take INTUNIV.
- Hypotension, bradycardia, and syncope were observed in clinical
trials. Decreases in blood pressure and heart rate were
dose-dependent and were less pronounced over time of treatment.
Heart rate and blood pressure should be measured prior to
initiation of therapy, following dose increases, and periodically
while on therapy. Use INTUNIV with caution in patients with a
history of hypotension, heart block, bradycardia, cardiovascular
disease, or syncope, or who may have a condition that predisposes
them to syncope; are treated concomitantly with antihypertensives
or other drugs that can reduce blood pressure or heart rate or
increase the risk of syncope. Advise patients to avoid becoming
dehydrated or overheated.
- Somnolence and sedation were commonly reported adverse
reactions in clinical studies. The potential for additive sedative
effects with CNS depressant drugs should be considered. Caution
patients against operating heavy equipment or driving until they
know how they respond to INTUNIV. Advise patients to avoid use with
alcohol.
- The most common adverse reactions (incidence ≥5% and at least
twice the rate for placebo) in the monotherapy trials with INTUNIV
were somnolence, fatigue, nausea, lethargy, and hypotension, and in
the adjunctive trial with INTUNIV were somnolence, fatigue,
insomnia, dizziness, and abdominal pain.
Please see Full Prescribing
Information, including Patient
Information.
About ADHD
Attention-Deficit/Hyperactivity Disorder is a neurobehavioral
disorder that manifests as a persistent pattern of inattention
and/or hyperactivity-impulsivity and is more frequent and severe
than is typically observed in individuals at a comparable level of
development.
ADHD is one of the most common childhood psychiatric disorders.
Although many people tend to think of ADHD as a childhood problem,
60% to 85% of children with ADHD may continue to meet the criteria
for the disorder during their teenage years. Nearly 50% of children
with ADHD may continue to meet the criteria for the disorder in
adulthood, based on parent-report. The disorder is 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,
approximately 10 million adults are estimated to have ADHD. Drug
treatment may not be appropriate for all patients with ADHD.
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 specified in the
Diagnostic and Statistical Manual of MentalDisorders,
4th Edition, Text Revision (DSM-IV-TR®) or International
Classification of Diseases, 10th revision
(ICD-10).
Although there is no cure for ADHD, there are accepted
treatments that have been demonstrated to improve symptoms.
Standard treatments include educational approaches, psychological
therapies which may include behavioral modification, and/or
medication.
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead
better lives.
Our strategy is to focus on developing and marketing innovative
specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases,
Gastrointestinal, Internal Medicine and Regenerative Medicine and
we are developing treatments for symptomatic conditions treated by
specialist physicians in other targeted therapeutic areas.
http://www.shire.com
FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical
facts are forward-looking statements. 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 adversely
affected. The risks and uncertainties include, but are not limited
to, that:
- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion;
- the failure to obtain and maintain reimbursement, or an
adequate level of reimbursement, by third-party payors in a timely
manner for Shire's products may impact future revenues and
earnings;
- Shire relies on a single source for manufacture of certain of
its products and a disruption to the supply chain for those
products may result in Shire being unable to continue marketing or
developing a product or may result in Shire being unable to do so
on a commercially viable basis;
- Shire uses third party manufacturers to manufacture many of its
products and is reliant upon third party contractors for certain
goods and services, and any inability of these third party
manufacturers to manufacture products, or any failure of these
third party contractors to provide these goods and services, in
each case in accordance with its respective contractual
obligations, could adversely affect Shire's ability to manage its
manufacturing processes or to operate its business;
- the development, approval and manufacturing of Shire's products
is subject to extensive oversight by various regulatory agencies
and regulatory approvals or interventions associated with changes
to manufacturing sites, ingredients or manufacturing processes
could lead to significant delays, increase in operating costs, lost
product sales, an interruption of research activities or the delay
of new product launches;
- the actions of certain customers could affect Shire 's ability
to sell or market products profitably and fluctuations in buying or
distribution patterns by such customers could adversely impact
Shire's revenues, financial conditions or results of
operations;
- investigations or enforcement action by regulatory authorities
or law enforcement agencies relating to Shire's activities in the
highly regulated markets in which it operates may result in the
distraction of senior management, significant legal costs and the
payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including
Shire's ability to obtain, maintain, enforce and defend patents and
other intellectual property rights required for its business, could
have a material adverse effect on Shire's revenues, financial
condition or results of operations;
and other risks and uncertainties detailed from time to time in
Shire's filings with the U.S. Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K.
VIU-05006 05/13
Vyvanse® and INTUNIV® are registered
trademarks of Shire LLC.
For further information please
contact:
Investor Relations
Eric
Rojas, erojas@shire.com, +1-781-482-0999
Sarah
Elton-Farr, seltonfarr@shire.com,
+44-1256-894157
Media
Jessica Mann, jmann@shire.com,
+44-1256-894-280
Gwen Fisher, gfisher@shire.com,
+1-484-595-9836
