SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Not Required

Inclusion Criteria:

The subject cannot be enrolled in the study before all of the following inclusion criteria
(including test results) are met:

1. Subject is between 18-55 years of age.

2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders
Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:

3. Subject has a BED diagnosis.

4. Subject's BED is of at least moderate severity with subjects reporting at least 3
binge eating days per week.

5. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine
pregnancy test and agree to comply with any applicable contraceptive requirements.

Exclusion Criteria:

Subjects are excluded from the study if any of the following exclusion criteria are met:

1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.

2. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior
therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED.

3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their
BED.

4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.

5. Subject is considered a suicide risk, has previously made a suicide attempt, or is
currently demonstrating active suicidal ideation.

6. Subject has known history of symptomatic cardiovascular disease, advanced
arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart
rhythm abnormalities, coronary artery disease, or other serious cardiac problems.

7. Subject has a history of moderate or severe hypertension.

8. Subject is female and pregnant or nursing.

9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures
for weight loss.