Significant reduction in AISRS total score from CFB to EOS1
Adults 18 years and older
Inattention and hyperactivity/impulsivity symptom score reductions observed as early as week 2.1
Qelbree was studied in 4 clinical trials. In the flexible-dose study of adults 18 to 65 years of age, ADHD symptom score reductions were statistically significant in patients taking Qelbree, beginning at week 2.1,2
Qelbree is the first non-stimulant approved for adult ADHD in over 20 years1,3
Phase III trials methodology1
The clinical trial was a randomized, double-blind, placebo-controlled, multicenter, parallel-group, flexible-dose study.
CFB to EOS in AISRS total score, Qelbree treatment group.
Inclusion criteria to include: males or females ages 18 to ≤65 years; ADHD diagnosis (DSM-5) ≥6 months before screening, confirmed with SCID-5-CT; AISRS total score ≥26 at the screening baseline visits; BMI=18.0 to 35 kg/m2; CGI-S score of >4 at the screening baseline visits; FOCP: sexually inactive/using birth control from 30 days before the first dose through completion.
Exclusion criteria to include: previously enrolled in a Qelbree/SPN-812 study; HAM-A score of >21 at screening; SDQ mean score >3.5 at screening (before March 2020), >3.0 at screening (after March 2020); suicidality within 6 months; major psychiatric disorder; major neurological disorder; history of seizures; significant systemic disease; positive drug screen; FOCP: pregnancy, breastfeeding, refusal of abstinence/birth control.
Abbreviations: AISRS, ADHD Investigator Symptom Rating Scale; BMI=body mass index; CGI-S, Clinical Global Impression–Severity of Illness; FOCP, female of childbearing potential; HAM-A, Hamilton Anxiety Rating Scale; SCID-5-CT, Structured Clinical Interview for DSM-5, Clinical Trials Version; SDQ, Symptoms of Depression Questionnaire.
Simple to start
Age group: Adults, 18 to 65 years of age
ITT population: N=354
Study medication: Flexible dosing (200 mg to 600 mg) or matching placebo
No study visit was scheduled/performed at week 5
Proven efficacy in a robust clinical trial1
Primary efficacy measure: CFB to EOS in AISRS total score vs placebo1 (N=354)
Qelbree Flexible Dosing Results: Patients were titrated to receive 200 mg/day for week 1, 400 mg/day for week 2; and from week 3 to EOS, the investigators could titrate up or down by 200 mg/day each week. Percentage of patients treated by dose at EOS (n=189):
200 mg/day: 8%
400 mg/day: 32%
600 mg/day: 60%
Study P306 results:
Total AISRS score at EOS was significantly reduced in adults treated with Qelbree vs placebo. The CFB in AISRS total score at EOS (LS mean +/- SE) was -15.5 (+/- 0.91) for Qelbree and -11.7 (+/-0.90) for placebo.1
- Once-daily Qelbree delivers significant symptom score reductions on the subscales of both inattention and hyperactivity/impulsivity in adults1
- Once-daily Qelbree demonstrates proven safety and tolerability with no evidence of abuse potential observed in clinical studies1,4
Abbreviations: ADHD-RS-5, Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th ed; AEs, adverse events; CFB, change from baseline; EOS, end of study; LS mean, least squares mean; SE, standard error.