Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPD503-AM · 1 trial · 1 indication
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
| Arm | Type | Description |
|---|---|---|
| SPD503-AM | EXPERIMENTAL | SPD503 (Guanfacine Extended Release) |
| SPD503-PM | EXPERIMENTAL | SPD503 (Guanfacine Extended Release) |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SPD503-AM | DRUG | SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg |
| SPD503-PM | DRUG | SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg |
| Placebo | DRUG | Placebo matched to Guanfacine Hydrochloride Extended Release |
Inclusion Criteria: * Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks * Aged 6-17 years with a sub-optimal * Partial response to stimulants * Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
SPD503-AM is an investigational small molecule being developed for the treatment of attention deficit hyperactivity disorder (ADHD). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
SPD503-AM is being developed by Takeda Pharmaceutical Company Limited, which is publicly traded under the ticker symbol TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ADHD.
SPD503-AM is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 3 clinical trial has been completed to assess its efficacy and safety in combination with psychostimulants for ADHD.
SPD503-AM has one completed Phase 3 clinical trial registered as NCT00734578, titled 'Efficacy and Safety of SPD503 in Combination With Psychostimulants.' This randomized, double-blind, placebo-controlled study enrolled 461 participants aged 6 years and older with ADHD in the United States.
SPD503-AM is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. A completed Phase 3 trial has evaluated its use in combination with psychostimulants for ADHD, but regulatory approval has not been granted.