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

Inclusion Criteria -

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

2. Subject meets the following DSM-IV-TR criteria for a diagnosis of BED:

Recurrent episodes of binge eating. An episode of binge eating is characterized by
both of the following: eating, in a discrete period of time (eg, within a 2-hour
period) an amount of food that is definitely larger than most people would eat in a
similar period of time under similar conditions, and a sense of lack of control over
the eating (eg, a feeling that one cannot stop eating or control what or how much one
is eating).

The binge eating episodes are associated with at least 3 of the following: eating
much more rapidly than normal; eating until uncomfortably full; eating large amounts
of food when not feeling physically hungry; eating alone because of being embarrassed
by how much one is eating; feeling disgusted with oneself, depressed, or feeling very
guilty after overeating.

Marked distress regarding binge eating. The binge eating occurs, on average, at least
2 days a week for 6 months. The episodes of binge eating do not occur exclusively
during the course of bulimia nervosa or anorexia nervosa.

3. Subject's BED is of at least moderate severity with subjects reporting at least 3
binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as
documented in the subject's binge diary. A binge day is a day during which at least 1
binge eating episode occurs.

4. Female subjects must have a negative serum B HCG pregnancy test and a negative urine
pregnancy test.

Exclusion Criteria-

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
within 3 months.

3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their
BED within 6 months.

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

5. Subject is considered a suicide risk in the opinion of the investigator, has
previously made a suicide attempt, or is currently demonstrating active suicidal
ideation. Subjects with intermittent passive suicidal ideation are not necessarily
excluded based on the assessment of the investigator.

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 recently initiated treatment with a lipid-lowering medication (within the
past 3 months).

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

9. Subject is female and pregnant or nursing.

10. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other
procedures for weight loss.