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FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

ADHD symptom control demonstrated from the first time point measured (1.5 hours) through 13 hours postdose

PHILADELPHIA, June 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment VYVANSE(R) (lisdexamfetamine dimesylate) CII, to include supplemental data that demonstrated significant ADHD symptom control in children aged 6 to 12 from the first time point measured (1.5 hours) through 13 hours postdose. VYVANSE is now the first and only oral ADHD stimulant treatment to have 13-hour postdose efficacy data for pediatric patients included in its product labeling.

"Children with ADHD who still exhibit symptoms into the evening might need a treatment that provides a long duration of effect from morning, through homework and family time," said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. "The FDA approval of this labeling change for VYVANSE provides important additional information for physicians on the duration of effect of VYVANSE and use as a once daily treatment option."

This update to the VYVANSE product labeling is based on a 13-hour analog classroom study that demonstrated improvements in behavior, inattention, and math test scores in children aged 6 to 12 from the first time point measured (1.5 hours) through the last time point assessed (13 hours) postdose. This study supports the results of a previous Phase 2 laboratory school study in which VYVANSE demonstrated ADHD symptom control from the first time point assessed (two hours postdose) with duration of efficacy up to 12 hours postdose. The adverse events in the 12-hour study for patients taking VYVANSE during the double-blind treatment period, which were greater than or equal to 2 percent, were insomnia, decreased appetite, and anorexia.

VYVANSE Demonstrated Significant Efficacy Versus Placebo at 13 Hours Postdose

The study that led to this approval of revised labeling for VYVANSE was a randomized, double-blind, placebo-controlled, analog classroom study that assessed the efficacy and safety of VYVANSE in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The second group received placebo the first week and their optimal dose of VYVANSE the second week.

The primary objective of this study was to assess the time of onset of VYVANSE compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives included assessment of the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D scale, and assessment of efficacy and time of onset of VYVANSE compared with placebo as measured by SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales.

In the study, VYVANSE demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. Further, VYVANSE treatment was associated with significant efficacy as measured by both subjective (SKAMP-D and SKAMP-A) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day, and at all time points in between (2.5, 5.0, 7.5, 10.0 and 12.0 hours).

Safety was also evaluated during the study. The most frequently reported adverse events (greater than or equal to 10 percent and twice placebo) in the dose optimization phase for patients taking VYVANSE were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and affect lability (mood swings).

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 dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. To date, more than 5 million VYVANSE prescriptions have been filled, bringing the current market share to 12 percent based on weekly branded prescription volume. Additionally, VYVANSE formulary coverage has been positive, with 10 of 11 top managed care plans covering the product in a preferred formulary position.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and 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.

Additional information about VYVANSE and Full Prescribing Information, including Medication Guide, are available at


Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and one controlled trial in adults.

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); seizures; 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 thought 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.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.

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 healthcare provider may stop Vyvanse treatment if a problem is found during these check-ups.

Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.

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.

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, approximately 9.8 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 syndrome. 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-TR) 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 medication.


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 website:


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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