FDA Approves Daytrana® (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents

DUBLIN and PHILADELPHIA, July 6 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years.  Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years.  Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

"The FDA approval of Daytrana for adolescents now extends this medication option to an additional group of ADHD patients who may benefit from ADHD treatment delivered by a patch," said Mike Yasick, senior vice president of the Shire ADHD business unit.  "This approval reinforces Shire's commitment to providing a varied and comprehensive portfolio of medicines to meet the diverse needs of ADHD patients."

The efficacy of Daytrana was demonstrated in a multi-center, 7-week, phase 3b, randomized, double-blind, placebo-controlled study in 217 adolescents aged 13 to 17 diagnosed with ADHD.  The primary efficacy measure was the mean change in ADHD Rating Scale-IV (ADHD-RS-IV) total score.  The Daytrana treatment group demonstrated significant reduction (indicating improvement) in ADHD-RS-IV total score from baseline to endpoint compared with placebo (P<.001). The most commonly reported adverse reactions associated with Daytrana (greater than or equal to 5% and twice the rate of placebo) in this study were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia (persistent loss of appetite).  The majority of subjects in the study had erythema (redness or rash) at the application site.

Daytrana is a transdermal patch that is applied to intact skin and delivers methylphenidate through the skin into the bloodstream.  It is recommended that Daytrana be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application.  The effects can continue for several hours after the patch is removed.  With guidance from the prescribing physician, Daytrana can be removed earlier than 9 hours if a shorter duration of effect is desired and/or to help manage potential late-day side effects.  This flexibility allows parents, working with physicians, to tailor the treatment to a patient's specific needs and to accommodate changing schedules.  Daytrana is available in patch strengths of 10 mg, 15 mg, 20 mg, and 30 mg (nominal dose delivered over a 9-hour wear time). The prescribing physician should titrate the dose of DAYTRANA to the desired effect.

Please see accompanying Full Prescribing Information, including Boxed Warning regarding potential for abuse and dependence.

Daytrana is licensed globally to Shire by Noven Pharmaceuticals, Inc.

Indication

Daytrana is indicated for the treatment of Attention Deficit Hyperactivity Disorder in children and adolescents aged 6 to 17 years.  The efficacy of Daytrana was established in two controlled 7-week clinical trials in children and one controlled 7-week trial in adolescents.

Daytrana 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

Daytrana should not be used in patients who have an allergy to methylphenidate or other patch components; marked anxiety, tension, or agitation; glaucoma; tics or diagnosis of a family history of Tourette's syndrome; seizures; are being treated (or within 14 days after treatment) with monoamine oxidase inhibitors (MAOIs).

Stimulant products generally should not be used in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. 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. A careful patient history, including family history, and physical exam should be taken to assess the presence of cardiac disease. Patients reporting symptoms of cardiac disease (ie, exertional chest pain, 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. Use cautiously with pressor agents.

Use of Daytrana may lead to contact sensitization; Treatment should be discontinued if contact sensitization is suspected.  Mild to moderate erythema has been commonly reported and is not by itself an indication of sensitization.  Patients should avoid applying external heat to the Daytrana patch.

Use with caution in patients with a history of: psychosis; EEG abnormalities; bipolar disorder; depression. Hematologic monitoring is advised during prolonged treatment. New psychosis, mania, aggression, visual disturbances, and growth suppression, have been associated with the use of stimulants. 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.

In addition to application site reactions, the most commonly reported adverse reactions associated with Daytrana (greater than or equal to 5% and twice the rate of placebo) in clinical trials were: children -  decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability and anorexia; adolescents – decreased appetite, nausea, insomnia, decreased weight, dizziness, abdominal pain and anorexia. Leaving the patch on for greater than the recommended 9 hours could lead to a higher incidence of adverse events.

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).

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 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 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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