DAYTRANA Treatment for Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) inability or condition which prevents a person from being able to focus and concentrate on task or a purpose. This interferes in developing social relationships or self-esteem. Common symptoms seen in children with ADHD include impulsive behavior (Sometimes act without thinking), hyperactivity, disruptive (“can’t sit still”), mood or depression in about eighteen percent of children with ADHD, anxiety disorder affecting about 25 percent of children with ADHD (excessive worry, fear or panic), and aggressiveness behavior in a classroom or social settings. Aggression behavior can be characterized by oppositional defiance or stubbornness, in at least 35 percent of children with ADHD. The hyperactive and impulsive behavior is apparent far more in a child’s age. These symptoms may appear over a period of many months or may not emerge for a year or more. Approximately 7.8 percent of school-age children or about 4.4 million children in United States diagnosed having AGHD, a psychiatric disorder in children, and adolescents. Boys are about three times more likely than girls to be diagnosed with ADHD. Being diagnosed having Attention Deficit Hyperactivity Disorder must have pass specific requirements or standard of tests. The inappropriate behavior must appear early in life, before age of seven, and continue for at least six months. The behavior characteristics must create at least two handicap inability’s, which maybe apparent in a schoolroom, playground, at home or social settings. A child that is overly active in a playground only or some other interactive area, and otherwise shows normal behavior in other social settings, is not diagnosis having ADHD. Also, behavior of ADHD can be excluded when linked to stress home, related to divorce, a move, an illness, changing schools or simply at times becoming forgetful. Attention Deficit Hyperactivity Disorder probably caused by genetics. Also, links smoking during pregnancy, premature delivery, low birth weight, and injuries to the brain at birth. Researchers have found that areas of the brain are about five to ten percent smaller in size in children with ADHD. People with ADHD are like to have a family member with Attention Deficit Hyperactivity Disorder or related conditions. Medications are available to control the symptoms of ADHD, along with behavioral therapy.

In June 2006, Shire plc announced the availability of DAYTRANA (methylphenidate transdermal system), transdormal medication approved by the Food and Drug Administration in April 2006, for the treatment of symptoms related to Attention Deficit Hyperactivity Disorder. Subsequently, in December 2005 the Psychopharmacologic Drug Advisory Committee recommended to the US FDA that DAYTRANA is safe and effective. DAYTRANA developed by Noven Pharmaceuticals (NASDAQ: NOVN) incorporated (headquarters in Miami, Florida.). Active ingredient is methylphenidate and Noven’s patented DOT Martix(tm) transdermal technology, which provides continuous release of the medication throughout the day. Noven’s prescription patches have been approved in over 30 countries, and a range of new patches being developed in collaboration with other pharmaceutical companies. The active ingredient methylphenidate is used in oral medication such as Ritalin and Concerta. DAYTRANA should be applied daily to clean, dry skin, area free of any cuts or irritation. During a child’s normal daily activity, the patch is designed to stay on, even during swimming, exercising or bathing. Recommended by the manufacture nine-hour wear time providing duration effect of twelve hours. During clinical trials of children aged six to twelve years old, efficacy of the patch become apparent after the first two hours of application. DAYTRANA should be available in retail pharmacies in June or July 2006, in dosage strength of 10 mg, 15 mg, 20 mg, and 30 mg and packages of ten patches for titration and 30 patches for ongoing therapy. According to Mathew Emmens, Shire Executive Officer “The availability of DAYTRANA, the first and only patch for ADHD provides physicians and parents with a new practical way to individualize treatment.”

Leading investigator of DAYTRANA, Robert Finding, M.D. director of adolescent and child psychiatry at Case Western Reserve said the approval of this treatment for ADHD, offers clinicians a therapeutic option that may be preferable to standard oral therapy.

Reported side effects taking DAYTRANA, include decreased appetite, insomnia (When the patch is worn longer than recommended nine hours.), nausea, vomiting, weight loss and tics. Skin irritation or allergic skin rash may occur. Caution to parents or guardians, abuse of methylphenidate may lead to dependence. Children that have heart conditions, high blood pressure, problems with alcohol or drugs, depression, bipolar disorder, visual disturbances or seizures, the attending physician should be notified and may advise another course of treatment. Methylphenidate is not advisable for children with significant agitation, glaucoma, family history or diagnosis of Tourette’s syndrome or taking MAO inhibitors (a type of antidepressant). Some children might be allergic taking methylphenidate. The medication should not be used for the prevention or treatment of severe depression or normal fatigue states.

Shire and Noven have a financial agreement regarding DAYTRANA. In 2003, Shire provided payment to Noven for $25 million, and provided to make a separate milestone payments up to $125 million: $50 million will be paid upon approval by the FDA and $75 million conditioned upon the achievement of certain sales targets.