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Methylphenidate Patch Provides Individualized Symptom Management

Shorter Wear Time Provides Shorter Duration of Effect, Offering Individualized ADHD Symptom Management

SAN DIEGO, CA -- October 27, 2006 -- Shire plc announced that its Attention Deficit Hyperactivity Disorder (ADHD) patch, Daytrana(TM) (methylphenidate transdermal system), has significant efficacy in reducing the symptoms of ADHD in children aged 6 to 12 years, even when the ADHD patch is taken off earlier than the recommended nine hours.

The ability to remove the patch earlier than the recommended nine-hour wear time allows physicians the opportunity to manage the potential for late-day side effects, such as lack of appetite or difficulty sleeping. These phase 3b clinical trial results were reported today at a major scientific and educational meeting of child and adolescent psychiatrists in San Diego, Calif.

"The patch's delivery system offers physicians individualized control of their patients' ADHD symptoms, adding an important dimension to the treatment of ADHD, since a child's schedule often varies between school day and weekend," explained Timothy E. Wilens, MD, Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School.

"Because it is a patch, if a child sleeps late on the weekend and the patch is applied later than on a school day, it can still be removed at the usual time. That way, the child receives the benefit of their long-acting ADHD medication for a shorter duration of effect, as well as managing the potential for late-day side effects. The physician, in consultation with the parent, can determine the appropriate patch wear time, up to the recommended nine hours," he said.

Shire's Daytrana is the first and only patch medication approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms of pediatric ADHD. Daytrana is available in four dosage strengths -- 10 mg, 15 mg, 20 mg and 30 mg -- all designed for once-daily use. When worn for the recommended nine hours, efficacy has been demonstrated from the first time point measured (two hours) through the 12-hour time point.

Noven Pharmaceuticals, Inc. developed Daytrana, which combines the active ingredient, methylphenidate, with Noven's patented DOT Matrix(TM) transdermal technology. This transdermal delivery system was designed to provide continuous medication release throughout the day. The patch is designed to stay on during the normal daily activities of a child such as swimming, exercising or bathing.

Significant Symptom Control With Daytrana When Worn for Four or Six Hours
In this study, investigators researched the duration of symptom control of Daytrana when the patch was worn for four and six hours compared to a placebo patch. Study results were based on the children's scores on the primary study measure, the standard Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale deportment (SKAMP-D), a standardized, validated classroom assessment tool used for evaluating the behavioral symptoms of ADHD. Higher SKAMP-D ratings reflect greater impairment.

Improvement in the SKAMP-D scores for both the four- and six-hour wear time groups was seen at the first time point measured (2 hours), compared to placebo. When Daytrana was removed after four and six hours of wear time, mean SKAMP-D scores began to return toward baseline within two hours of patch removal. A similar effect was observed by the Permanent Product Measure of Performance (PERMP) test of the number of math problems attempted and completed correctly.

Study Design
In the three-way cross-over study, 117 children aged 6 to 12 years diagnosed with ADHD were started on the 10-mg patch, and the dosage was increased during a five-week period until the optimal Daytrana dose was reached. The laboratory classroom study period covered three weeks including one classroom laboratory day per week, with the patients wearing the patch for nine hours for days in between the classroom laboratory days. Then, on the three laboratory classroom days only, the researchers randomized the children to treatment with a placebo patch or a Daytrana patch and either four- or six-hour wear times, but neither the investigators nor the children knew which treatment was received until study end. The results reported in this poster were based on analyses of the intent-to-treat population.

Study Safety Information
Daytrana was generally well-tolerated during this study. Adverse events typically were mild to moderate and were consistent with known effects of methylphenidate. The most common adverse events seen in the trial included: decreased appetite, headache, insomnia and upper abdominal pain.

The study was supported by funding from Shire.

Important Safety Information
Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.

Daytrana should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.

Tell your doctor before using Daytrana if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts 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 your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana.

Daytrana was generally well tolerated in clinical studies. The most common side effects reported with Daytrana were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using Daytrana.

Abuse of Daytrana can lead to dependence.

Patients converting from another formulation of methylphenidate should start on the 10-mg Daytrana patch. Daytrana should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin irritation or allergic skin rash may occur.

For Full Prescribing Information on Daytrana, please visit http://www.Daytrana.com or call Shire Medical Affairs at 1-800-828-2088, option 1.

About ADHD
Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most common psychiatric disorders in children and adolescents. ADHD is a neurobiological psychiatric 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. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; at least six of nine symptoms of hyperactivity/impulsivity; the onset of such symptoms before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning.

Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.

Daytrana(TM) is a trademark of Shire Pharmaceuticals Ireland Limited.


SOURCE: Shire plc

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