Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SPN-810
Molindone · 5 trials · 5 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.
Safety Assessments include: Adverse Events, clinical lab tests, vital signs, physical examinations, ECGs, Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS) and Columbia Suicise Severity Rating Scale (C-SSRS)
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 |
| Molindone | OTHER | Extension study, all subjects will be given Molindone at different (established) dosage levels based on the patient's weight, response and investigator discretion. |
| 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. |
| Molindone | DRUG | The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion. |
| 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...
Molindone is being developed by Supernus Pharmaceuticals as a treatment for impulsive aggression comorbid with ADHD in children. It is an investigational small molecule in Phase 2 clinical development and is not approved for this use. The completed Phase 2 trial enrolled 78 pediatric patients aged 6 years and older in the United States.
Molindone targets the serotonin 2A receptor (HTR2A) and the dopamine D2 receptor (DRD2), acting as an antagonist at both. By blocking these receptors, molindone modulates serotonergic and dopaminergic signaling, which are pathways implicated in impulsive aggression and ADHD symptoms in children.
Supernus Pharmaceuticals, Inc. (ticker: SUPN) is developing molindone for impulsive aggression comorbid with ADHD in children. The company is the sponsor of the Phase 2 clinical program evaluating this small molecule in pediatric patients.
Molindone is in Phase 2 clinical development for impulsive aggression comorbid with ADHD in children. It is investigational and has not been approved by the FDA for this indication. The Phase 2 program includes one completed trial with 78 enrolled patients.
Molindone has been studied in one completed Phase 2 trial, NCT01416064, titled an open-label extension study to 810P202. The trial enrolled 78 children aged 6 years and older with impulsive aggression comorbid with ADHD in the United States. It was an uncontrolled, open-label study and is no longer active.