Shire announces new update to BED medication labeling
Bibliographic record
Abstract
Vyvanse (lisdexamfetamine dimesylate) labeling has been updated to include information regarding the approval of a supplemental New Drug Application by the Food and Drug Administration (FDA). The labeling will now include maintenance of efficacy data from the first‐ever longer‐term pharmacologic study (38 weeks) in adults with moderate‐to‐severe binge eating disorder (BED), Shire officials announced. The data were presented at a few medical conferences including the Eating Disorders Association of Canada in September, and during the American College of Neuropsychopharmacology Annual Meeting a year ago. The updated labeling is based on a long‐term study showing that adults with moderate‐to‐severe BED who responded to Vyvanse were much more likely to stay in remission than if they stayed on placebo, Susan L. McElroy, M.D., professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine, told CPU.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.013 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.007 | 0.007 |
| Insufficient payload (model declined to judge) | 0.040 | 0.020 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".