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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 Extended-release Guanfacine Hydrochloride, extended-release guanfacine hydrochloride (SPD503)
Guanfacine · 5 trials · 3 indications
Systolic Blood pressure was measured at supine and standing position and mean supine systolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication \[Visit 19/Early Termination (ET)/Day 714\].
Diastolic Blood pressure was measured at supine and standing position and mean supine diastolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Pulse was measured at supine and standing position and mean supine pulse was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
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.
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. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.
Treatment failure was defined as \>= 50% increase (worsening) in ADHD-RS-IV total score and a \>= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.
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 |
|---|---|---|
| Extended-release Guanfacine HCl | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Extended-release Guanfacine Hydrochloride | EXPERIMENTAL | - |
| Atomoxetine Hydrochloride | OTHER | Active Reference |
| Extended-release Guanfacine Hydrochloride (SPD503) AM | EXPERIMENTAL | - |
| SPD503 PM | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Extended-release Guanfacine HCl (Intuniv, SPD503) | DRUG | Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age |
| Extended-release Guanfacine Hydrochloride | DRUG | The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on weight. |
| Placebo | OTHER | Matching placebo will be provided as 1,2,3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on weight. |
| Atomoxetine Hydrochloride | DRUG | Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose |
| Placebo Comparator | DRUG | Placebo |
| extended-release guanfacine hydrochloride (SPD503) | DRUG | dosed in AM |
Inclusion Criteria: 1. Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent/caregiver is sat...
Guanfacine is used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is an extended-release small molecule developed by Takeda Pharmaceutical Company Limited and studied in children and adolescents aged 6 to 17 years. The clinical program includes five completed Phase 3 trials with a total enrollment of 1,735 participants.
Guanfacine targets the alpha-2 adrenergic receptors ADRA2A, ADRA2C, and ADRA2B, where it acts as an agonist. By binding these receptors, it modulates noradrenergic signaling in the central nervous system, which is the basis for its use in Attention Deficit Hyperactivity Disorder. It is a small molecule administered as an extended-release formulation.
Guanfacine is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda conducted the extended-release guanfacine hydrochloride clinical program, including the Phase 3 trials SPD503-315 and SPD503-316 referenced in the European access study NCT01500694.
Guanfacine is in Phase 3 development for Attention Deficit Hyperactivity Disorder. Five Phase 3 trials have been completed, and none are currently active. The studies were randomized, double-blind, and placebo-controlled, with a combined enrollment of 1,735 participants across the program.
Completed Phase 3 trials of guanfacine include NCT01500694, an access study for participants from SPD503-315 or SPD503-316; NCT01244490, an efficacy and safety study in children and adolescents aged 6 to 17; NCT01081145, a maintenance of efficacy study; and NCT01081132, a dose-optimization study in adolescents aged 13 to 17.
Yes, guanfacine is also known as extended-release guanfacine hydrochloride, extended-release guanfacine HCl, Intuniv, and SPD503. These names refer to the same extended-release small molecule developed by Takeda for Attention Deficit Hyperactivity Disorder, so searches under any of these terms point to the same asset.