Supernus Pharmaceuticals, Inc. announced the presentation of two posters at Psych Congress 2023 with new data showing improved efficacy in children ages 6 years and older with ADHD when Qelbree is added to a stimulant, as well as in adults with ADHD who undergo long-term treatment with Qelbree. Results from Phase IV Safety Trial of Concomitant Use with Psychostimulants in Children and Adolescents with ADHD When added to existing psychostimulants, Qelbree demonstrated a favorable safety and tolerability profile as well as a significant improvement in ADHD symptoms in pediatric patients (6-17 years), regardless of timing of dosing. This study illustrates the versatility of Qelbree to address patient needs, including standalone usage and combination therapy, regardless of dosing time.

Final Results from Long-term, Phase III, Open-label Extension Trial in Adults with ADHD. Concomitant outcomes from a long-term, open-label extension (OLE) trial of the double-blind pivotal Phase III study that led to the U.S. Food and Administration (FDA)-approval of Qelbree in adults with ADHD, found that adult patients (N=159) saw an improvement in ADHD symptoms and executive function with safety and tolerability similar to the initial trial. adults received 200mg of Qelbree every day for one week, increased to 400mg, and then optimized over twelve weeks up to 600mg per day (200-600mg per day).

Patients in this open-label trial received Qelbree for 265 (254.9) days. Patients ADHD symptoms improved from 37.9 (6.34) to 19.7 (12.16) on the Adult ADHD Investigator Symptom Rating Scale (AISRS), representing average symptom reduction of -18.2 (11.54). Patients executive function improved from 70.4 (10.94) to 58.3 (16.19) on the BRIEF-A Global Executive Composite scale, representing improvement in executive function of -12.9 (13.48).

The treatment related adverse events (TRAEs) seen in this long-term trial were consistent with those seen in the short-term pivotal adult trial. The most commonly occurring TRAEs reported with the use of Qelbree were insomnia (11.3%), nausea (9.4%), headache (5.7%), and fatigue (10.1%). AEs led to discontinuation in 17.6% of patients.