Shire to Initiate Two Phase 4 Clinical Trials to Compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII)
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 with ADHD
PHILADELPHIA, PA, USA – March 06, 2012 – As part of its continued commitment to ADHD research, Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced it is initiating two Phase 4 clinical trials to compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (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 ClinicalTrials.gov.
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 individual patient.
Concerta® is a registered trademark of ALZA Corporation.
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, 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 events.
■Contraindications: Known hypersensitivity to amphetamines or other ingredients in Vyvanse. 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 prompt evaluation.
■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 aggressive behavior.
■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 interrupted.
■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 (≥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, 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 Prescribing Information for Vyvanse (lisdexamfetamine dimesylate), including Boxed WARNING regarding Potential for Misuse, Abuse, Addiction, and Diversion.
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 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®) 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:
+1 781 482 0999
+44 1256 894157
Jessica Mann (Corporate)
+44 1256 894 280
Gwen Fisher (Specialty Pharma)
+1 484 595 9836
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: www.shire.com.
Vyvanse® is a registered trademark of Shire LLC.
"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 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.