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 nonstimulant 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.