Published Study Demonstrated Once-Daily Vyvanse® (lisdexamfetamine dimesylate) Capsules CII Provided Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD

PHILADELPHIA, Aug. 5 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that a Phase 3b study published in Behavioral and Brain Functions found adults with Attention Deficit Hyperactivity Disorder (ADHD) who took once-daily Vyvanse® (lisdexamfetamine dimesylate) Capsules CII demonstrated significant improvement in attention.  This improvement was measured by average of Permanent Product Measure of Performance (PERMP) total scores of all six time points measured across the assessment day (two, four, eight, 10, 12 and 14 hours after administration) as well as at each time point measured.  This is the first study published in a peer-reviewed journal to demonstrate efficacy data for adults at 14 hours postdose of an oral long-acting stimulant medication for ADHD approved by the U.S. Food and Drug Administration (FDA).

Vyvanse is a prescription medicine for the treatment of ADHD.  Efficacy was based on two controlled trials in children aged six to 12 and two controlled trials in adults.  Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.

"Because ADHD symptoms may extend into the evening for many adults, the availability of treatments that provide symptom improvement throughout the day is important," said Matthew Brams, M.D., study author and Clinical Assistant Professor of Psychiatry at Baylor College of Medicine.  "Physicians who want to help their adult patients manage their ADHD symptoms beyond the work day may want to consider Vyvanse, which has demonstrated significant efficacy throughout the day, even at 9 PM when taken at 7 AM."

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence.  Keep Vyvanse in a safe place to prevent misuse and abuse.  Selling or giving away Vyvanse may harm others, and is against the law.

About the Study

This study was designed to assess safety, efficacy and duration of Vyvanse in adults with ADHD using an objective assessment measured at different time points throughout the day, in a modified analog classroom study to simulate a workplace environment.

This multi-center, randomized, double-blind, placebo-controlled, crossover study in 142 adults who met DSM-IV-TR® criteria for ADHD evaluated the efficacy and safety of three once-daily doses of Vyvanse.  Following a four-week, open-label, dose-optimization phase with Vyvanse (30, 50, or 70 mg/day in the morning), subjects were randomized to one of two treatment sequences:  Vyvanse (optimized dose) followed by placebo, each for one week, or placebo followed by Vyvanse, each for one week.  Efficacy assessments occurred at the end of each week using PERMP.  The PERMP is a skill-adjusted math test that measures attention in ADHD.  Vyvanse treatment, compared to placebo, resulted in a statistically significant improvement in attention across all postdose time points, as measured by average PERMP total scores over the course of one assessment day, as well as at each time point measured.  The PERMP assessments were administered at predose (-0.5 hours) and at two, four, eight, 10, 12 and 14 hours postdose.

In addition to PERMP, the investigators measured the efficacy of Vyvanse using the ADHD-RS with adult prompts.  In this study, Vyvanse demonstrated a reduction of approximately 52 percent from baseline in average ADHD-RS total scores in adults.  Adult patients taking placebo demonstrated a reduction of approximately 21 percent in average ADHD-RS total scores.

The most frequently reported treatment-emergent adverse events reported by five or more percent of patients during the dose-optimization phase were decreased appetite, dry mouth, headache, insomnia, upper respiratory tract infection, irritability, nausea, anxiety, feeling jittery, diarrhea, and fatigue.  

This study was supported by funding from Shire Development Inc.  Dr Timothy Wilens has received research support and consulting honoraria from Shire.  Dr John Giblin has received grant support from Shire and has served as a consultant to Shire.  Dr Wilens, Dr Giblin and Dr Matthew Brams have been speakers for Shire.  Dr Maria Gasior, Dr Joseph Gao and Dr Liza Squires are full-time employees of Shire Development Inc.

About Vyvanse

Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged six to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six once-daily 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.  After oral ingestion, it is converted to pharmacologically active d-amphetamine.

Sudden death, stroke, and myocardial infarction (heart attack) 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 while taking Vyvanse should be promptly evaluated.  Use with caution in patients whose underlying medical condition might be affected by an increase in blood pressure or heart rate.

Additional information about Vyvanse and Full Prescribing Information and Medication Guide, including Warning about Potential for Abuse, are available at http://www.vyvanse.com.

INDICATION AND IMPORTANT SAFETY INFORMATION

Vyvanse is a prescription medicine for the treatment of ADHD. Efficacy was based on two controlled trials in children aged six to 12 and two controlled trials in adults.  Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.

Vyvanse is a stimulant medicine.  Abuse of stimulants may lead to dependence. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.  These events have also been reported rarely with stimulant use.

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); 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 thoughts 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.

Talk to your health care provider if your child experiences slowing of growth (height and weight).  Children should have their height and weight checked periodically while taking Vyvanse.  Your health care provider may stop Vyvanse treatment if a problem is found during these check-ups.

The most common side effects reported in studies of Vyvanse were upper belly pain, dry mouth, weight loss, irritability, vomiting, nausea, dizziness, trouble sleeping and decreased appetite.

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.

For additional safety information, please see Full Prescribing Information and Medication Guide, including Warning about Potential for Abuse, and discuss with your doctor.

About ADHD

Attention Deficit Hyperactivity Disorder (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.  

ADHD is one of the most common childhood psychiatric disorders.  In the United States, approximately 7.8 percent of all school-age children have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC).  Although many people tend to think of ADHD as a childhood problem, 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, approximately 9.8 million adults are believed 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, Fourth Edition, Text Revision (DSM-IV-TR®) or International Classification of Diseases, Tenth revision (ICD-10).

Although there is no cure for ADHD, there are accepted treatments that help control its symptoms.  Standard treatments include educational approaches, psychological therapies which may include 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 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.

SOURCE Shire plc

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