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ADHD Spokesperson, Celebrity Team Up Announcing VYVANSE For Adult ADHD Treatment

2008-07-24 08:37

Shire Limited (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has launched VYVANSE (lisdexamfetamine dimesylate) for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD). This launch of adult ADHD treatment follows the recent FDA approval of VYVANSE to treat ADHD in the adult population. VYVANSE is now available in U.S. pharmacies nationwide in six once-daily dosage strengths. To raise awareness of ADHD in adults and recognize the launch of VYVANSE for adults, Shire has partnered with celebrity designer Ty Pennington to shine the spotlight on living as an adult with ADHD. Pennington takes VYVANSE as part of his treatment plan to manage his ADHD symptoms so he can focus and get work done.

Pennington returns today to his hometown of Atlanta, where he will visit the Savannah College of Art and Design-Atlanta (SCAD-Atlanta) and announce the Daily Successes with ADHD Scholarship for an adult with ADHD who is pursuing an education or career in a creative field at SCAD-Atlanta. The $10,000 scholarship, sponsored by Shire, the maker of VYVANSE, will benefit an adult with ADHD who is enrolled in, or applying to, a graduate program at the art institution. The objective of the scholarship is to recognize achievements, and to motivate a student to continue to focus and achieve daily successes.

"As an adult with ADHD, I know, firsthand, the importance of understanding and treating ADHD. I believe if I'd been diagnosed and treated earlier, I would have struggled less as a child," said Ty Pennington, host of ABC's Extreme Makeover: Home Edition™. "Today, I have a very demanding schedule with long production days and constant travel, and I take VYVANSE to help control my ADHD symptoms so that I can focus and organize."

ADHD Can Affect Adults' Daily Lives In adults with ADHD, symptoms can impact their professional life, social life, relationships and personal finances. In a new survey conducted by Shire of adults who experienced ADHD symptoms in a typical week, 88 percent of 328 adults surveyed reported that they have difficulty organizing tasks and activities, while 89 percent of 381 of these adults had difficulty finishing things, such as projects or work at home. These adults reported that this has had a negative impact on their daily life and activities. Additionally, among the 347 adults surveyed who are currently employed, 66 percent felt that they would do a better job at work if they were more focused and organized.

"Although ADHD can affect children and adults, the core symptoms of the disorder, inattention, hyperactivity, and impulsivity, may present differently in these two patient groups. For example, hyperactivity may present in adults as inner restlessness and inattention may present as a lack of focus and organization, poor time management, and an inability to finish tasks," said David W. Goodman, M.D., director of the Adult Attention Deficit Disorder Center of Maryland and assistant professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine. VYVANSE is one of several treatment options that may provide effective treatment control for adults with ADHD. In a clinical study, VYVANSE was shown to significantly improve ADHD symptoms within the first week: inattention - such as the ability to focus and organize - and hyperactivity and impulsivity - such as restlessness, and interrupting."

Shire received approval in April 2008 from the FDA for VYVANSE for the treatment of ADHD in adults aged 18 to 55 years. VYVANSE was introduced in July 2007 for the treatment of ADHD in children aged 6 to 12 years. VYVANSE is available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. In its first year of availability, more than 2 million VYVANSE prescriptions have been filled.

VYVANSE works with the body's natural metabolism to deliver active medication. VYVANSE is a once-a-day capsule that should be taken in the morning with or without food as prescribed by your doctor.

Additional information about VYVANSE and Full Prescribing Information are available at http://www.vyvanse.com.

Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and one controlled trial in adults.

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

Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought 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 the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.

Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.

Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.

ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged 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 Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to access a wide range of DSM-IV disorders. When this percentage is extrapolated to the full U.S. population, approximately 9.8 million adults are believed to have ADHD. ADHD is a neurobiological 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; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears 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 and the symptoms cannot be better explained by another psychiatric disorder.

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.

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Comments

As one of several adults treated with other amphetamine (either Dexedrine or Adderall) stims who agreed to test Vyvanse for ADD/ADHD, I can state that at least in our group (#10), this drug was at best a dud, at worst, promoted extreme aggression and depression. All participants reduced the use of their usual stims but because Vyvanse IS adderall or the mixed amphetamine salts compound, reactions between different chemicals was not a concern. NO one felt that one Vyvanse (no matter what dosage used) was "one-a-day". Every person noted a fall-off, however smooth, by 3PM. All persons felt more irritable and short-fused around 5PM and had to take their regular meds. Almost 60% of the group reported feelings during the Vyvanse-dosed pert of the day of heightened aggressive behavior and/or depression and 2 persons felt such despair that they had suicide ideations (something NEVER experienced on their usual amphetamine meds). Plus 100% of testers experienced dry mouth to varying degrees. Two persons experienced diuretic symptoms that interfered with their workday, although it is unknown whether this effect could be the result of attempts to alleviate the dry mouth. In 75% moderate to severe stomach ache and/or nausea was observed almost every day; and reduced appetite was noted by 100% of testers. All testers also experienced headaches shortly after taking the daily dose; 40% noted headaches in addition during random times throughout the day. Elevated BP (from their normal) were reported by 30% of the group. Finally only 2 persons were able to take Vyvanse for the entire 14-day period. Most persons withdrew by Day 7 (#6); one person withdrew Day 8; one person withdrew Day 11. NOT ONE PARTICIPANT SAID THAT THEY WANTED TO CHANGE FROM THEIR ORIGINAL AMPHETAMINE MEDS TO VYVANSE. THEY FELT THAT EVEN WITH ELIMINATING THE SIDE EFFECTS, THEY DID NOT OBSERVE ANY IMPROVEMENT IN THEIR ABILITY TO CONCENTRATE OR LEARN. (Note: this 14-day test was conducted completely unofficially, and only to see if Vyvanse lived up to the hype. All participants were and continue to be evaluated at least every 3 months by psychiatrists who legally prescribed said medications.) The Shire company better have LOTS of cash put away for the lawsuits that will show in about 6 months.