Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPD503 · 7 trials · 6 indications
The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.
The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.
Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
| Arm | Type | Description |
|---|---|---|
| SPD503 (Guanfacine hydrochloride) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| SPD503 (Guanfacine HCl) (1 mg) | EXPERIMENTAL | - |
| SPD503 (2 mg) | EXPERIMENTAL | - |
| SPD503 (3 mg) | EXPERIMENTAL | - |
| SPD503 (4 mg) | EXPERIMENTAL | - |
| SPD503 (Guanfacine HCl) (2 mg) | EXPERIMENTAL | - |
| SPD503 | ACTIVE_COMPARATOR | - |
| SPD503 (Guanfacine HCl) | EXPERIMENTAL | - |
| A: SPD503 (4mg) | ACTIVE_COMPARATOR | - |
| B: VYVANSE (50mg) | ACTIVE_COMPARATOR | - |
| C: SPD503 (4mg) + VYVANSE (50mg) | ACTIVE_COMPARATOR | - |
| Concerta | ACTIVE_COMPARATOR | - |
| SPD503 + Concerta | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SPD503 (Guanfacine hydrochloride) | DRUG | Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day). |
| Placebo | DRUG | Placebo |
| SPD503 (1 mg) | DRUG | - |
| SPD503 (2 mg) | DRUG | - |
| SPD503 (3 mg) | DRUG | - |
| SPD503 (4 mg) | DRUG | - |
| SPD503 (Guanfacine hydrochloride) (2 mg) | DRUG | - |
| SPD503 (extended-release Guanfacine hydrochloride) | DRUG | Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance). |
| SPD503 (Guanfacine HCl) | DRUG | - |
| SPD503 | DRUG | SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. |
| VYVANSE | DRUG | VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. |
| SPD503 and VYVANSE | DRUG | SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. |
| Concerta | DRUG | CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets. |
| SPD503 + Concerta | DRUG | SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together). |
Inclusion Criteria: * Healthy subjects with ADHD and oppositional symptoms * ADHD-RS\>=24 * CGI \>=4 * T-score of Opp subscale CPRS-R:L \>=65 * Normal ECG and BP * \>= 55 lbs
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
SPD503 is an investigational small molecule being studied in psychiatry for attention deficit hyperactivity disorder (ADHD) and generalized anxiety disorder (GAD). It has been evaluated in clinical trials for these conditions, as well as in healthy volunteers for drug interaction studies.
SPD503 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has sponsored clinical trials of the drug across multiple phases and indications.
SPD503 has completed Phase 3 clinical trials for ADHD, along with Phase 1 and Phase 2 studies. It remains an investigational drug and is not approved by the FDA, as it is still in clinical development.
SPD503 has been studied in several completed trials, including NCT00367835, a Phase 3 trial in ADHD with oppositional symptoms, and NCT01470469, a Phase 2 trial in generalized anxiety disorder, separation anxiety disorder, and social phobia. Phase 1 drug interaction studies include NCT00901576 and NCT00919867.
SPD503 is also known as guanfacine hydrochloride, as indicated in the title of the Phase 3 trial NCT00367835. This name reflects the drug's active ingredient, which is being evaluated for its effects in ADHD and other psychiatric conditions.