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SPN-810 · 4 trials · 4 indications
The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the Baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 6, inclusive) and baseline period (Day ≤1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period.
The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a "0" and the highest score is "198". A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).
| Arm | Type | Description |
|---|---|---|
| Low dose SPN-810 (18 mg) | EXPERIMENTAL | Oral |
| High dose SPN-810 (36 mg) | EXPERIMENTAL | Oral |
| Placebo | PLACEBO_COMPARATOR | Oral |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| Treatment 1 | EXPERIMENTAL | Treatment 1: SPN-810 5mg/day for subjects \<30kg and 10mg/day for subjects ≥30kg |
| Treatment 2 | EXPERIMENTAL | Treatment 2: SPN-810 10mg/day for subjects \<30kg and 20mg/day for subjects ≥30kg. |
| Treatment 3 | EXPERIMENTAL | Treatment 3: SPN-810 15mg/day for subjects \<30kg and 30mg/day for subjects ≥30kg. |
| Treatment 4 | EXPERIMENTAL | Treatment 4: SPN-810 20mg/day for subjects \<30kg and 40mg/day for subjects ≥30kg. |
| Name | Type | Description |
|---|---|---|
| SPN-810 (18 mg) | DRUG | Subjects were randomized to receive SPN-810 9 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. |
| SPN-810 (36 mg) | DRUG | Subjects were randomized to receive SPN-810 18 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. |
| Placebo | DRUG | Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. |
| SPN-810 | DRUG | administered orally |
Inclusion Criteria: * Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication. * Impulsive aggression will be confirmed at screening using R-MO...
SPN-810 is an investigational small molecule being developed for the treatment of impulsive aggression comorbid with attention-deficit/hyperactivity disorder (ADHD). It is also studied in patients with ADHD and persistent serious conduct problems. The drug is intended for use in children aged 6 years and older.
SPN-810 is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol SUPN. The company is conducting clinical trials to evaluate the safety and efficacy of SPN-810 in pediatric patients with ADHD-related impulsive aggression.
SPN-810 has completed Phase 2 and Phase 3 clinical trials. Two Phase 2 studies and two Phase 3 studies have been completed. The drug remains investigational and is not yet approved by regulatory authorities. Its development status reflects data from these completed trials.
SPN-810 has been studied in four completed clinical trials. NCT00626236 was a Phase 2a safety and tolerability study in children with ADHD and conduct problems. NCT01364662 was a Phase 2 efficacy study in impulsive aggression with ADHD. NCT02618408 and NCT02618434 were Phase 3 trials (CHIME 1 and CHIME 2) in ADHD with impulsive aggression.
SPN-810 is a small molecule designed to address impulsive aggression in children with ADHD. Its specific mechanism of action has not been disclosed in available clinical trial information. The drug is being evaluated as an adjunctive therapy to standard ADHD treatment.
SPN-810 is a distinct investigational compound developed by Supernus Pharmaceuticals. It is not identified as being the same as any other marketed ADHD medication. Its development focuses on treating impulsive aggression, a specific comorbidity of ADHD, rather than core ADHD symptoms alone.