Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vyvanse · 1 trial · 1 indication
The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Vyvanse (lisdexamfetamine dimesylate) | DRUG | Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day). |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Subject is a male or female aged 6-12 years inclusive at the time of consent. 2. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
Vyvanse is used for the treatment of attention deficit/hyperactivity disorder (ADHD). It is a small molecule psychiatric medication being developed by Takeda Pharmaceutical Company Limited. The drug has been studied in a Phase 3 clinical trial for this indication.
Vyvanse is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The drug is a small molecule being studied for the treatment of ADHD in the therapeutic area of psychiatry.
Vyvanse is in Phase 3 clinical development. It has completed one Phase 3 trial for ADHD. The drug is investigational and has not been approved by regulatory authorities based on the available information.
Vyvanse has been studied in one completed Phase 3 clinical trial with the identifier NCT00500149. This was a randomized, double-blind, placebo-controlled classroom study that assessed the time of onset of Vyvanse in pediatric subjects aged 6-12 with ADHD.
Yes, Vyvanse is the brand name for lisdexamfetamine dimesylate. The clinical trial NCT00500149 specifically evaluated Vyvanse (lisdexamfetamine dimesylate) in pediatric subjects with ADHD, confirming that these names refer to the same drug.