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Label indication INTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14) ]. INTUNIV is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications ( 1 , 14 ). FDA label
Also known as SPD503 (Guanfacine HCl), SPD503 (extended-release Guanfacine hydrochloride), SPD503 (Guanfacine hydrochloride), Intuniv, Guanfacine hydrochloride (TAK-503)
SPD503 · 5 trials · 5 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 | - |
| 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 | - |
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 |
| Axsome Therapeutics, Inc. | AXSM | 3 | PHASE3 | Solriamfetol |
SPD503 is being studied for attention deficit hyperactivity disorder (ADHD) and for generalized anxiety disorder (GAD). Its clinical program also includes children and adolescents with separation anxiety disorder and social phobia. The ADHD studies enrolled children and adolescents aged 6 to 17 years, and the anxiety study covered the same age range.
SPD503 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the clinical program for the drug, including the Phase 3 ADHD trials and the Phase 2 anxiety trial.
SPD503 has been studied in Phase 3 clinical trials, which are completed. Three Phase 3 studies in ADHD have finished, along with a Phase 2 trial in generalized anxiety disorder, separation anxiety disorder, and social phobia. SPD503 is an investigational small molecule and is not described as approved.
SPD503 has been evaluated in completed trials including NCT00152009 and NCT00150618, both Phase 3 ADHD studies in children and adolescents aged 6 to 17, and NCT00367835, a Phase 3 study in ADHD with oppositional symptoms. NCT01470469 was a Phase 2 trial in generalized anxiety disorder, separation anxiety disorder, and social phobia.
Yes, SPD503 is an extended-release formulation of guanfacine hydrochloride. The alternative names used for this asset include SPD503 (Guanfacine HCl), SPD503 (extended-release Guanfacine hydrochloride), and SPD503 (Guanfacine hydrochloride), with the 1 mg and 2 mg strengths also referenced under the SPD503 name.
Across the SPD503 clinical program, 851 participants were enrolled in total. The trials were randomized, double-blind, and placebo-controlled, and all four listed studies are completed. Enrollment ranged from 83 participants in the Phase 2 anxiety trial to 345 in the largest Phase 3 ADHD study.