FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD

PHILADELPHIA, May 4 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment Vyvanse® (lisdexamfetamine dimesylate) Capsules CII, to include supplemental data demonstrating significant improvement in attention in adults with ADHD across all six assessments conducted at two, four, eight, 10, 12 and 14 hours after administration as measured by average Permanent Product Measure of Performance (PERMP) total scores, as well as at each time point measured.  Vyvanse is now the first and only oral ADHD long-acting stimulant treatment to have efficacy data at 14 hours postdose for adult patients included in its product labeling.

"The availability of an ADHD treatment for adults that provides efficacy throughout the day and into the evening is important as adults may need to manage their symptoms beyond the work day," said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. "Shire is pleased with the FDA approval of this labeling change for Vyvanse."

The update to the Vyvanse product labeling is based on a 14-hour modified analog classroom study of Vyvanse to simulate a workplace environment in 142 adults who met DSM-IV-TR criteria for ADHD.  The data support the results of a previous Phase 3 clinical study of adults with ADHD in which Vyvanse significantly improved the ADHD symptoms of inattention (for example, lack of focus), as well as of hyperactivity and impulsivity, as measured by the ADHD Rating Scale (ADHD-RS-IV) with adult prompts, a standard validated tool.  The most common treatment-emergent adverse events in patients taking Vyvanse in this previous study were decreased appetite, trouble sleeping, dry mouth, nausea, diarrhea, anxiety and loss of appetite.

As with other stimulant medications, Vyvanse is classified as a controlled substance (CII) because of its potential for abuse.

About the Study

The data that led to this approval of revised labeling for Vyvanse was from a multi-center, randomized, double-blind, placebo-controlled, crossover study in 142 adults who met DSM-IV-TR criteria for ADHD.  Following a 4-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 the 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 (approximately 52 percent) from baseline in average ADHD-RS total scores in adults, from 37.2 at baseline to 18.1 at end point.  Adult patients taking placebo demonstrated a reduction (approximately 21 percent) in average ADHD-RS total scores, from 37.2 at baseline to 29.6 at end point.

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 (trouble sleeping), upper respiratory tract infection, irritability, nausea, anxiety, anorexia, diarrhea, and fatigue.

About Vyvanse

Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 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.  The conversion of Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times.

Sudden death, stroke, and myocardial infarction 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, including the Medication Guide, are available at http://www.vyvanse.com.

INDICATION AND IMPORTANT SAFETY INFORMATION

Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and two controlled trials in adults. Vyvanse is indicated as an integral part of a comprehensive treatment program that may include other measures (psychological, educational, social).

Amphetamines have a high potential for abuse; prolonged administration may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. See Full Prescribing Information for complete Boxed WARNING.

Vyvanse should not be taken by patients who have advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncrasy to sympathomimetic amines; agitated states; glaucoma; a history of drug abuse; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction 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 such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.

New psychosis, mania, aggression, growth suppression, visual disturbances and exacerbation of tics and Tourette's syndrome have been associated with the use of stimulants. Use with caution in patients with a history of psychosis, seizures or EEG abnormalities, bipolar disorder, or depression. Growth should be monitored in children during treatment with stimulants, and patients who are not growing (gaining height or weight) as expected may need to have their treatment interrupted.

The most common adverse reactions (greater than or equal to 5 percent and at least twice the rate of placebo) reported in the pivotal clinical trials were pediatric – decreased appetite, insomnia, upper abdominal pain, irritability, decreased weight, vomiting, nausea, dizziness and dry mouth; adult – decreased appetite, insomnia, dry mouth, nausea, diarrhea, anxiety and anorexia.

For Full Prescribing Information, including the Medication Guide about Vyvanse, please visit http://www.vyvanse.com.

About ADHD

ADHD is one of the most common psychiatric disorders in children and adolescents.  Worldwide prevalence of ADHD is estimated at 5.3 percent (with large variability), according to a comprehensive systematic review of this topic published in 2007 in the American Journal of Psychiatry.  In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC).  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, almost 10 million adults are believed to have ADHD.

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.  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 such as Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV®) or International Classification of Diseases 10 (ICD-10).

Although there is no cure for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, psychological or 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 .

THE "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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