A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder

Inclusion Criteria

• 1. Male or female subject between 18-55 years of age, inclusive, at time of informed consent.
• Subject meets the following DSM-5 criteria for a diagnosis of BED. An episode of binge eating is characterized by both:
• Eating an amount of food larger than what most people would eat, in a discrete period of time (eg, 2 hours)
• Sense of lack of control over eating episode

Binge eating episodes are associated with ≥ 3 of the following:

• Eating much more rapidly than normal
• Eating until uncomfortably full
• Eating large amounts when not feeling hungry
• Eating alone because of embarrassment
• Feeling disgusted with oneself, guilty afterward Binge eating episodes are also associated with marked distress regarding the episode and not associated with recurrent use of compensatory behavior (eg, bulimia nervosa). Note: A subject using compensatory behavior less than 1 time every 2 weeks over the 3 months prior to screening may be permitted to enroll in the study.
• Diagnosis is confirmed based on the Structured Clinical Interview for DSM-IV Axis I Disorders, Module H (SCID-I Module H), clinician review of subject diaries, and the EDE-Q.
• Subject has a BED diagnosis or is diagnosed at screening and has a history of at least 2 binge eating days a week for at least 6 months prior to screening.
• Subject's BED is of at least moderate severity with subject reporting at least 3 binge eating days for each of the 2 weeks prior to baseline as documented in the subject's binge diary. A binge eating day is defined as having at least one binge eating episode 6. Subject has a BE- CGI-S score ≥ 4 at screening and baseline. 7. Subject has a negative breath alcohol test and a negative UDS for any illicit drug.
• Female subject must have a negative serum pregnancy test at screening; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
• Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
• Subject must be able to comply with study drug administration and adhere to protocol requirements including all study assessments.
• Subject can read well enough to understand the informed consent form and other subject materials

Exclusion Criteria

• Subject has BMI of 18 kg/m2or less, or greater than 45 kg/m2.
• Subject has a lifetime history or current symptoms consistent with bulimia nervosa or anorexia nervosa.
• Subject has started psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) within 3 months prior to screening. Note: Subjects receiving stable ongoing psychotherapy for longer than 3 months are permitted to enroll.
• Subject has participated in a formal weight loss program (eg, Weight Watchers®) within 3 months prior to screening.
• Subject has used a psychostimulant or mood stabilizer within the 3 months prior to screening.
• Subject has used any medications for the treatment of binge eating, other eating disorders, obesity, or weight gain or any other medication that could result in weight gain or weight loss including over-the-counter and herbal products within the 3 months prior to screening.
• Subject has received lisdexamfetamine dimesylate (Vyvanse®) for any reason, including but not limited to participation in any Phase 2 or 3 trial.
• Subject has a lifetime history of psychotic disorder, bipolar disorder, hypomania, dementia, or ADHD as defined by the DSM-5 criteria.
• Subject has a history of moderate to severe depression based on Investigator's judgment within the 6 months prior to screening or is currently takin