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06 Feb 2012
INTUNIV® (guanfacine) Extended-Release Tablets Dosed Once Daily Effective as Adjunctive Therapy to Stimulants for Treatment of ADHD

Data on the adjunctive use of a once-daily nonstimulant in children and adolescents with ADHD published in Journal of the American Academy of Child & Adolescent Psychiatry

Philadelphia, PA – February 6, 2012 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced the publication of data for once-daily INTUNIV® (guanfacine) Extended-Release Tablets as adjunctive therapy to stimulants for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17 in the Journal of the American Academy of Child & Adolescent Psychiatry. Findings show that treatment with INTUNIV given in combination with a stimulant led to significant improvements in ADHD symptoms from baseline as measured by ADHD Rating Scale IV (ADHD-RS-IV) total score, the primary efficacy measure of the study.1

“These data demonstrate INTUNIV as a valuable treatment option for the approximately 30 percent of children and adolescents with ADHD who are having a suboptimal response to their current stimulant therapy,” said Matthew Brams, MD, Bayou City Research, Houston, TX, and investigator on the study. “In this study, INTUNIV was also found to be effective when taken as adjunctive therapy in the morning or the evening, giving physicians flexibility when it comes to treating patients with ADHD.”

INTUNIV is indicated for the treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. 2 INTUNIV is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).2 INTUNIV is the only once-daily ADHD medication approved for administration as adjunctive therapy to stimulants. INTUNIV should not be taken by individuals concomitantly taking other guanfacine-containing products or by those with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine (eg, TENEX®).2

During the 9-week, multicenter, double-blind, randomized, placebo-controlled study, patients (N=455) experiencing a suboptimal response* to stimulant treatment for ADHD were randomized to receive a morning or evening dose of INTUNIV (1 mg, 2 mg, 3 mg, or 4 mg) or placebo in combination with their prescribed dose of a stimulant.1 Clinicians reported significantly greater improvement from baseline to endpoint in ADHD-RS-IV total score, which includes both hyperactive/impulsive and inattentive subscales, in patients receiving INTUNIV and a stimulant, when INTUNIV was dosed either in the morning or evening, compared with patients receiving placebo and stimulant.1

The most commonly observed adverse reactions (incidence greater than or equal to 5 percent and at least twice the rate for placebo) in this adjunctive trial were somnolence, fatigue, insomnia, dizziness, and abdominal pain. The majority of events were mild or moderate in severity and no unique events were observed with INTUNIV given with a stimulant compared with those reported historically for either treatment alone. There were no serious treatment-related adverse events seen in this study.  Three percent of patients receiving INTUNIV plus a stimulant discontinued from the study due to adverse events, compared to 1 percent in the placebo plus stimulant group.1

“These data for INTUNIV strengthen its position in the ADHD treatment portfolio—one that may help to address symptoms that many children with ADHD still experience while on stimulant treatment,” said Michael Yasick, Senior Vice President of Shire’s ADHD Business Unit. “Every situation is different when it comes to treating ADHD, and we are pleased to offer physicians a number of treatment options for ADHD.”

*Suboptimal response was defined as treatment with a stable dose of stimulant for at least four weeks with improvement, yet persistence of mild to moderate ADHD symptoms in the opinion of the investigator (defined as an ADHD-RS-IV total score of at least 24, CGI-S score of at least three). Patients with no response to stimulants prior to study enrollment were excluded from participating in this study.1

Indication

INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. The effectiveness of INTUNIV for more than 9 weeks has not been systematically evaluated. The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.

INTUNIV is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

Important Safety Information

Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine (eg, TENEX®) should not take INTUNIV.

Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, heart block, bradycardia, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy. Advise patients to avoid becoming dehydrated or overheated.

Somnolence and sedation were commonly reported adverse reactions in clinical studies (38% for INTUNIV vs. 12% for placebo in monotherapy studies and 18% for INTUNIV vs. 7% for placebo in the adjunctive study). The potential for additive sedative effects with CNS depressant drugs should be considered. Patients should be cautioned against operating heavy equipment or driving until they know how they respond to INTUNIV. Advise patients to avoid use with alcohol.

Guanfacine, the active ingredient in INTUNIV, is also approved as an antihypertensive. Do not use INTUNIV in patients concomitantly taking other guanfacine-containing products (eg, TENEX®).

The most common adverse reactions (incidence ≥5% and at least twice the rate for placebo) in the monotherapy trials with INTUNIV were somnolence, fatigue, nausea, lethargy, and hypotension, and in the adjunctive trial with INTUNIV were somnolence, fatigue, insomnia, dizziness, and abdominal pain.

Please see Full Prescribing Information.

About INTUNIV

Once-daily INTUNIV is available in four doses—1 mg, 2 mg, 3 mg, and 4 mg.2 The active ingredient in INTUNIV is guanfacine. INTUNIV is not a central nervous system (CNS) stimulant or a controlled substance, and has no known potential for abuse or dependence.2 INTUNIV is a selective alpha-2A agonist. The mechanism of action of guanfacine in ADHD is not known.2

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.3

ADHD is one of the most common childhood psychiatric disorders.4 In the United States, the prevalence of ADHD is approximately three to seven percent in school-aged children according to the Centers for Disease Control and Prevention (CDC).5

The specific etiology of ADHD is unknown, and there is no single diagnostic test for this disorder.4 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).3,4

Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms.4 Standard treatments include educational approaches, psychological therapies that may include behavioral modification, and/or medication.4

 

For further information, please contact

Investor Relations  
Eric Rojaserojas@shire.com+1 781 482 0999
Sarah Elton-Farrseltonfarr@shire.com+44 1256 894157
Media  
Jessica Mannjmann@shire.com+44 1256 894 280
Matthew Cabreymcabrey@shire.com+1 484 595 8248

 

Notes to editors

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, 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.

 

"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.

 

References:

  1. Wilens T, Bukstein O, Brams M, et al. A controlled trial of extended-release guanfacine and psychostimulants for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2012;51(1):75-85.
  2. INTUNIV [package insert], Wayne, PA: Shire US Inc.
  3. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision (DSM-IV-TR ®). Washington, DC: American Psychiatric Association; 2000:85-93.
  4. Pliszka S and the AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
  5. Centers for Disease Control and Prevention. Increasing prevalence of parent reported attention deficit/hyperactivity disorder among children—United States, 2004 and 2007. Morb Mortal Weekly Rep (MMWR). 2010;59(44):1439-1443.

06 Feb 2012 INTUNIV® (guanfacine) Extended-Release Tablets Dosed Once Daily Effective as Adjunctive Therapy to Stimulants for Treatment of ADHD (165KB PDF)

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