FDA Approves Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents

PHILADELPHIA, Nov. 15, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents ages 13 to 17.  The approval is based on study data demonstrating that Vyvanse improved ADHD symptoms compared to placebo in adolescents with ADHD. Vyvanse is also indicated for the treatment of ADHD in children ages 6 to 12 years, and adults.

"This adolescent indication for Vyvanse is good news for kids in this age group diagnosed with ADHD and their caregivers as it offers an additional treatment option to help them manage their symptoms," said Mike Yasick, Senior Vice President of Shire's ADHD Business.  "The approval of Vyvanse for children and adults – and now for adolescents – underscores Shire's commitment to helping ADHD patients and their families."  

The FDA's approval of Vyvanse in adolescents was based on results from a randomized, double-blind, placebo-controlled, four-week, forced-dose escalation study of adolescents who received one of three Vyvanse doses, 30, 50 and 70 mg/day, or a placebo.  This study was conducted in 314 adolescents aged 13 to 17 who met DSM-IV-TR® criteria for ADHD.  In this study, patients were randomized to a daily morning dose of Vyvanse (30 mg/day, 50 mg/day or 70 mg/day) or placebo for a total of four weeks of treatment.  All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment. Subjects assigned to the 50 mg and 70 mg dose groups were escalated by 20 mg per week until they achieved their assigned dose.  The primary efficacy outcome was change in Total Score from baseline to end point in investigator ratings on the ADHD Rating Scale (ADHD-RS).  The ADHD-RS-IV rating scale is a measure of the core symptoms of ADHD.  The core symptoms of ADHD are inattention, hyperactivity and impulsivity. All Vyvanse dose groups were superior to placebo in the primary efficacy outcome.

The safety of Vyvanse was also evaluated during the study.  The most frequently occurring treatment-emergent adverse events (greater than or equal to 5 percent and twice placebo) reported in patients treated with Vyvanse were decreased appetite, insomnia, and weight decrease. Safety results were generally consistent with previous Vyvanse studies in children and adults.

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.  Vyvanse is a stimulant medication.  Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

Shire Development Inc. supported this study.  

About Vyvanse

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

INDICATION  

Vyvanse is a prescription medicine for the treatment of ADHD in children ages 6 to 17 and adults. Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION

• Vyvanse should not be taken by patients who have:

Heart disease or hardening of the arteries,  moderate to severe high blood pressure,  overactive thyroid gland (hyperthyroidism),  glaucoma, agitated states, a history of drug abuse, taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the last 14 days, or sensitivity to, are allergic to, or had a reaction to other stimulant medicines.  

• Vyvanse is a stimulant medicine. The following have been reported with use of stimulant medicines.

Heart-related problems:

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.  Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.

Mental (Psychiatric) problems:

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.  Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Vyvanse, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

• Serious side effects have been reported with use of stimulant medicines such as Vyvanse, including:
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision
  • motion and verbal tics.  Patients with tics or Tourette's syndrome may experience a worsening of symptoms while taking Vyvanse.
  • slowing of growth.  Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.

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• The most common side effects reported in studies of Vyvanse were:

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, up to 65 percent of children with ADHD may still exhibit symptoms in adulthood.  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, 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.

For further information please contact: Media: Matthew Cabrey, [email protected], +1-484-595-8248; or Cori Blair (Porter Novelli for Shire), [email protected], +1-212-601-8248

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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