FDA 2015: Vyvanse became the first medicine approved for moderate to severe binge eating disorder
On 30 January 2015 the FDA approved supplement S-037, adding moderate to severe binge eating disorder in adults to the Vyvanse label on the basis of new safety and effectiveness data. The label still says it is not for weight loss.
We have not finished checking this source. No judgement either way. how we score evidence
Caveat on this rating: Approval rests on two 12-week trials against placebo, not against psychological treatment; the lowest dose failed in phase 2.
The regulatory action that gave a stimulant a second approved use, and what the evidence behind it showed.
Significant findings
FDA's supplement approval letter for NDA 21977 (action date 30 January 2015) states that the Prior Approval supplement S-037 "provides for data supporting the safety and effectiveness of Vyvanse for the treatment of moderate to severe Binge Eating Disorder", approved "effective on the date of this letter". The same letter approved a separate labeling change, S-036, adding constipation to the postmarketing experience section.
The current label carries the evidence: two 12-week randomised, double-blind, placebo-controlled trials in adults aged 18 to 55 with moderate to severe binge eating disorder (374 and 350 participants), in which people on 50 or 70 mg had greater reductions in binge days per week than those on placebo, by 1.35 and 1.66 days. A randomised withdrawal study tested whether the effect held.
The other direction
The label also reports a phase 2 dose study in which 30 mg "was not statistically different from placebo". The approval added a use; it did not change the boxed warning on abuse, misuse and addiction, and the label states "VYVANSE is not indicated for weight loss." The trials were 12 weeks, with maintenance tested separately, so the approval says nothing about years of use.
What this does not show
It does not show stimulants are a first choice for binge eating disorder over psychological treatments, which these trials did not test against. It is not a reason to start or change any medicine.
Worth asking
For binge eating, what would therapy offer compared with medicine, and could we use both?
Source
Supplement approval letter, NDA 21977/S-036/S-037 (Vyvanse): moderate to severe binge eating disorder — US Food and Drug Administration, Center for Drug Evaluation and Research (2015)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- not recorded
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
We have not finished checking this source, so there is no scoring to show yet. “We have not checked this yet” and “this is disputed” are different statements, so no scored band is shown rather than a low one.
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "not yet assessed". We have not finished checking this source. No judgement either way. One caveat travels with that badge: Approval rests on two 12-week trials against placebo, not against psychological treatment; the lowest dose failed in phase 2. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Supplement approval letter, NDA 21977/S-036/S-037 (Vyvanse): moderate to severe binge eating disorder — US Food and Drug Administration, Center for Drug Evaluation and Research (2015). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: not recorded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.