FDA Approves SPD465 For Treatment Of ADHD In Adults

ADHD Treatment

Shire has received an approvable letter from the U.S. Food and Drug Administration for SPD465 an investigational oral stimulant intended to provide symptom control of ADHD in adults for up to 16 hours with one daily dose.

Following receipt of this approvable letter, Shire is evaluating its options related to SPD465.

Shire submitted a New Drug Application for SPD465 on July 21, 2006. If approved, SPD465 will be a treatment option for adults with ADHD and part of Shire's overall ADHD portfolio.

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 CDC. ADHD is one of the most common psychiatric disorders in children and adolescents. The disorder is also estimated to affect approximately 9.8 million adults across the U.S. based on a retrospective survey of adults aged 18 to 34, projected to the full U.S. adult population.(4,5) 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; 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.

In addition to SPD465, Shire's portfolio of ADHD treatments includes VYVANSE (lisdexamfetamine dimesylate), the first prodrug stimulant, which is planned to launch 2Q 2007, DAYTRANA (methylphenidate transdermal system), the first and only ADHD patch, and ADDERALL XR (mixed salts of a single-entity amphetamine product), a long-acting formulated stimulant. SPD503 (guanfacine HCl extended release) is currently under review with FDA.

SPD465, a single entity formulation of mixed amphetamine salts, was designed to provide extended release of medication with symptom control for up to 16 hours, is being studied for the treatment of ADHD in adults. The most common adverse events reported include insomnia, decreased appetite, dry mouth, headache and weight decrease.

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

VYVANSE or Adderall XR should not be taken by patients who have 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 your doctor before using, VYVANSE or Adderall XR if you or your child are being treated for or have symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; have abnormal thoughts or visions, hear abnormal sounds, or have been diagnosed with psychosis; have had seizures or abnormal EEGs; have or have had high blood pressure; exhibit aggressive behavior or hostility. Tell your doctor immediately if any of these conditions or symptoms develop while using VYVANSE or Adderall XR.