Shire to Initiate Two Phase 4 Clinical Trials to Compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII)
PHILADELPHIA, Pennsylvania, March 6, 2012 /PRNewswire/ –
Vyvanse, an approved treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in
patients ages 6 and above, will be compared with Concerta in the treatment of adolescents
As part of its continued commitment to ADHD research, Shire plc
[http://www.shire.com/shireplc/en/home ] (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced it is initiating two Phase 4 clinical trials to
compare Vyvanse(R) (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta(R)
(methylphenidate HCl) Extended-Release Tablets, (CII).
Prospectively designed head-to-head clinical trials provide important information to
physicians, patients, caregivers, and payors to make informed choices. There are no
prospectively designed, randomized, double-blind, head-to-head clinical trials comparing
the efficacy of these two frequently-prescribed medications for ADHD, making
evidence-based treatment decisions a challenge.
“These studies are important to further our understanding of the possible differences
in efficacy between Vyvanse and Concerta in treating adolescents with ADHD,” said Jeffrey
Jonas, MD, Senior Vice President of Research and Development for Shire’s Specialty
Pharmaceuticals and Regenerative Medicine businesses. “Shire’s investment in this
innovative program underscores our commitment to improving patient care by providing
prescribers with additional information on which to base treatment decisions.”
Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and
methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse
of amphetamines may cause sudden death and serious cardiovascular adverse events.
The two Phase 4 clinical trials are randomized, double-blind, multi-center,
parallel-group, active-controlled studies. They are designed to explore differences in
efficacy between Vyvanse and Concerta in adolescents ages 13 to 17 with ADHD. This
clinical trial program will utilize the clinician-administered ADHD-RS-IV Total Score to
compare the efficacy of Vyvanse to Concerta. One trial will employ a dose optimization
design and the other will employ a forced-dose titration schedule. Together the two trials
will enroll approximately 1,000 patients, and results are expected by second half of 2013.
Additional information about the clinical trial program will be available on
Shire recently completed a Phase 3, 8-week double blind, dose-optimized,
placebo-controlled study of Vyvanse in the treatment of ADHD in children and adolescents
in which Concerta was an active reference arm. Formal comparisons between Vyvanse and
Concerta were not planned as part of that study. However, the data do suggest this as an
area for further investigation. The data from this study have been presented previously at
a major psychiatry meeting in late 2011.
“It is important for practicing physicians to have access to information on
comparative efficacy of different approved medications when developing a personalized
treatment approach for individuals with ADHD,” said Jeffrey Newcorn, MD, Associate
Professor of Psychiatry and Pediatrics, Mount Sinai School of Medicine. “I expect the data
from these studies may aid prescribers in making individualized treatment decisions for
their adolescent patients with ADHD.”
Vyvanse should be used as part of a total treatment program that may include
counseling or other therapies. The physician who elects to use Vyvanse for extended
periods should periodically reevaluate the long-term usefulness of the drug for the
Concerta(R) is a registered trademark of ALZA Corporation.
ABOUT VYVANSE (lisdexamfetamine dimesylate)
Vyvanse [http://www.vyvanse.com ], 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, and approved in November 2010 to treat ADHD in adolescents ages 13
to 17, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg,
50 mg, 60 mg, and 70 mg.
Additional information about Vyvanse is available at http://www.vyvanse.com.
Vyvanse is indicated for the treatment of ADHD in patients ages 6 and above as part of
a total treatment plan that may include other measures (psychological, educational,
social). Efficacy was established in short-term controlled studies in children aged 6 to
17 and adults. Vyvanse is also approved as a maintenance treatment for adults with ADHD
based on one randomized withdrawal study. Extended use of Vyvanse should be periodically
reevaluated to determine its long-term usefulness for the individual patient.
IMPORTANT SAFETY INFORMATION
WARNING: POTENTIAL FOR MISUSE, ABUSE, ADDICTION, AND DIVERSION
See Full Prescribing Information for complete Boxed WARNING.
– Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and
methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion.
– Misuse of amphetamines may cause sudden death and serious cardiovascular adverse
– Contraindications: Known hypersensitivity to amphetamines or other ingredients in
Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been
observed in postmarketing reports. Using Vyvanse with monoamine oxidase inhibitors (MAOIs)
can result in hypertensive crisis. Stop MAOIs at least 14 days prior to Vyvanse use.
– Sudden death, stroke and myocardial infarction have been reported with stimulants at
usual doses for the treatment of ADHD. Stimulants generally should not be used in patients
with known structural cardiac abnormalities or other serious heart problems. Adults have a
greater likelihood than children of having such cardiac disease. Patients being considered
for stimulant treatment should have a careful history (including family history of sudden
death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac
disease. Further evaluation should be conducted if needed (eg, electrocardiogram and
echocardiogram). Patients who develop symptoms suggestive of cardiac disease (eg,
exertional chest pain, unexplained syncope) during stimulant treatment should undergo a
– Use with caution in patients whose underlying medical condition might be compromised
by increases in blood pressure or heart rate. Stimulants cause modest increases in average
blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm) and patients may
have larger increases. Monitor all patients for larger changes.
– Use of stimulants may cause psychotic or manic symptoms in patients with no prior
history, or exacerbation of symptoms in patients with pre-existing psychosis. Clinical
evaluation for bipolar disorder is recommended prior to stimulant use. Monitor for
– Monitor growth in children during treatment with Vyvanse. Children who are not
growing (gaining height or weight) as expected may need to have their treatment
– Stimulants may lower the convulsive threshold. Discontinue if seizures develop.
– Visual disturbances and exacerbation of tics and Tourette’s syndrome have been
reported with stimulant treatment.
– The most common adverse reactions (greater than or equal to5% 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, decreased weight, vomiting, nausea, dizziness and dry mouth; - Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight; - Adults: decreased appetite, insomnia, dry mouth, nausea, diarrhea, anxiety and anorexia.
Please click here for Full PrescribingInformation
[http://pi.shirecontent.com/PI/PDFs/Vyvanse_USA_ENG.pdf ] for Vyvanse (lisdexamfetamine
dimesylate), including Boxed WARNING regarding Potential for Misuse, Abuse, Addiction, and
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
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 into 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.
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 Mental Disorders, 4th Edition, Text Revision
(DSM-IV-TR(R)) 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.
Ongoing assessment and treatment may be necessary.
For further information please contact:
Notes to editors
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, human genetic therapies, gastrointestinal
diseases and regenerative medicine 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 website:
Vyvanse(R) is a registered trademark of Shire LLC.
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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 Pharmaceuticals, Human Genetic Therapies and
Regenerative Medicine products, as well as the ability to secure 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
third-party reimbursement for its products; and other risks and uncertainties detailed
from time to time in the Company’s filings with the Securities and Exchange Commission.
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SOURCE Shire plc