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Shire Announces Positive Results of 2-Year Study of Adderall XR(R) in the Treatment of Adult ADHD

Data Presented at U.S. Psychiatric & Mental Health Congress

LAS VEGAS, NV -- November 9, 2005 -- A study presented today demonstrated that adults with attention-deficit/hyperactivity disorder (ADHD) experienced significant long-term ADHD symptom control when treated with once-daily Adderall XR(R) (mixed salts of a single-entity amphetamine product).

The results of a 2-year, open-label trial led by Harvard Medical School investigators at Massachusetts General Hospital were presented today at the U.S. Psychiatric & Mental Health Congress in Las Vegas, NV.

"This study shows that this treatment can control the core symptoms of ADHD for longer periods of time," said lead investigator Joseph Biederman, MD, Professor of Psychiatry at Harvard Medical School.

Two hundred fifty-five adult patients participated in an initial four-week, multi-center, double-blind, placebo-controlled, parallel-group, forced-dose-escalation trial with Adderall XR. Two hundred twenty-one of these patients entered into a 24-month open-label extension study. Funding for this study was provided by Shire.

Investigators measured patients' symptoms using a validated ADHD Rating Scale (ADHD-RS). Results revealed that all patients maintained a significant average reduction in their ADHD symptoms when treated with Adderall XR, as measured by a change from baseline in mean ADHD-RS total scores (-7.2; P <.001).

Patients taking Adderall XR for the first time as part of the open- label extension study showed the most improvement (-11.6; P <.001; n=56) after 24 months in comparison to patients who continuously received Adderall XR treatment (-5.7; P <.001; n=144) and those whose treatment was interrupted between the initial study and the open-label extension (-6.0; P =.12; n=21). Investigators found similar significantly improved results in patients using the ADHD-RS hyperactivity/impulsivity and inattentive subscales.

Adderall XR exhibited a good tolerability profile during the trial at all doses. The approved dose for adult patients is 20 mg per day. The majority of side effects occurred in the first month of the trial, diminished over time and were generally mild or moderate in nature. The most frequently reported drug-related adverse events included dry mouth, insomnia, loss of appetite, headache and nervousness.

Additional Study Information
The average age of participants was 40 and all had a history of ADHD before age 7. Of the participants, about 60 percent were men and 90 percent were Caucasian. Many of the participants were not diagnosed until they were adults and reported that their symptoms had negatively impacted their lives prior to treatment. At the end of the trial, an evaluation of the validated Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Medication Satisfaction test revealed that patients were significantly satisfied with their treatment.

About ADHD
ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than typically observed in individuals at a comparable age and maturity level. Because everyone shows signs of these behaviors at times, the behaviors must appear early in life (before age 7 years) and continue for at least six months, according to the ADHD diagnosis criteria as defined in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR(R)). Up to 65 percent of children with ADHD may still exhibit symptoms into adulthood. In fact, approximately eight million American adults currently struggle with the inattention, impulsivity and hyperactivity symptoms of ADHD.

Without an effective treatment program, the symptoms of ADHD may lead to potentially serious consequences. A survey has shown that when compared to adults without ADHD symptoms, adults with untreated ADHD were more than twice as likely to have been arrested, 47 percent more likely to have received more than one speeding ticket in the last year, twice as likely to have been divorced and twice as likely to have held six or more jobs in the past decade. Further, evidence suggests that many adults with untreated ADHD may be at risk for other problems, including poor performance in the workplace and poor self-image.

Although there is no cure for ADHD, physicians and advocates are finding ways to help people with the condition learn to adapt to their school, home, social and work settings. ADHD usually can be successfully managed with behavioral therapy, structured coping techniques and medication. Psychostimulant medications are thought to stimulate areas of the brain that control attention, impulses, and self-regulation of behavior, remain among the most successful treatments for people with ADHD. Up to 70 percent of children with ADHD respond positively to psychostimulants. Medication should be considered part of an overall multi-modal treatment plan for ADHD.

About Adderall XR
Adderall XR(R) was generally well tolerated in clinical studies. The most common side effects in studies included: children -- decreased appetite, difficulty falling asleep, stomachache, and emotional lability; adolescents -- loss of appetite, difficulty falling asleep, stomachache, and weight loss; adults -- dry mouth, loss of appetite, difficulty falling asleep, headache, and weight loss.

Adderall XR may not be right for everyone. Patients should speak with their doctor if they have a history of high blood pressure or any heart conditions, glaucoma, thyroid problems, emotional instability, mental illness, or a known allergy to this type of medication. 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.

If you are currently taking or have recently taken a type of antidepressant called a MAO inhibitor or have a pre-existing structural heart abnormality, you should not take Adderall XR. There is a potential for worsening of motion or verbal tics and Tourette's syndrome. A patient should report any new psychological symptoms to his or her physician.


SOURCE: Shire Pharmaceuticals Inc.

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