Dosing Optimization for a Nonstimulant ADHD Treatment – Adult

DATA UPDATE

Qelbree adult dose optimization—
SHORT- AND LONG-TERM CLINICAL OBSERVATIONS

Resource to help optimize treatment with a nonstimulant for your adult patients 18 years and older.


INDICATION

Qelbree is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.

Please see full Important Safety Information to the top left.

What prompts you to further optimize ADHD treatment? 

Based on the phase III and OLE trials of ADHD patients 18 years of age and older^1,2...

Is further optimization warranted for your adult patients with ADHD taking Qelbree?

Abbreviations: ADHD, attention-deficit/hyperactivity disorder; OLE, open-label extension.

Adult phase III trial (P306): 92% of patients treated with Qelbree at EOS were on doses ≥400 mg/day²

Methodology¹: Randomized, double-blind, placebo-controlled, multicenter, parallel-group, flexible-dose study of adults 18 to 65 years of age (Study P306). Study medication¹: flexible dosing (200 mg/day to 600 mg/day) or matching placebo. No study visit was scheduled/performed at week 5. The primary endpoint was CFB at EOS (6 weeks) in AISRS Total Score with an established ADHD diagnosis (DSM-5) ≥6 months before screening, confirmed with the SCID-5-CT, and an AISRS total score ≥26 at the screening and baseline visits. Results¹: 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.

> How does this compare with the adult patients in your practice?        

Adult OLE trial (P311): total daily dose at 52 weeks²

Methodology²: Open-label, long-term, multicenter, flexible dose study of Qelbree in adults diagnosed with ADHD who completed Study P306; the OLE was conducted from January 2020 through July 2022. For patients with a rollover from P306 of <7 days, all efficacy and safety assessments collected at subjects’ EOS visit served as their efficacy and safety assessments for visit 1 (P311). For a rollover of >7 days, a screening visit for eligibility was scheduled and visit 1 baseline efficacy and safety were collected. All subjects entering the OLE received Qelbree 200 mg/day during the first 2 weeks of the study. At visit 2/W2, and all subsequent visits, the dose of Qelbree could be titrated up or tapered down in increments of 50 mg/day to 200 mg/day per week to a target dose within the range of 200 mg/day to 600 mg/day, based on subjects’ clinical response and tolerability. After week 12, subjects were allowed to use certain approved concomitant ADHD medications (n=9). Primary objective²: Collect long–term safety data on Qelbree monotherapy in the adult population.

Total daily dose of Qelbree in adults following 52 weeks of treatment in the OLE study²:

• OLE mean dose at week 52 was 421 mg/day (n=39)

> Are your patients getting to their optimized dose?        

Abbreviations: AISRS, ADHD Investigator Symptom Rating Scale; CFB, change from baseline; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, 5th edition; EOS, end of study; LS mean, least-squares mean; SCID-5-CT, Structured Clinical Interview for DSM-5-Clinical Trials; SE, standard error; W, week.

Optimizing treatment with once-daily Qelbree is straightforward

Once-daily Qelbree—Full-day exposure to medication in a single daily dose^1,2

Administration
Capsule can be taken whole or entire contents can be sprinkled over a spoonful of soft food (pudding or applesauce). Consume the mixture in its entirety, without chewing, within 15 minutes for pudding or within 2 hours for applesauce; do not store for future use.¹

• Capsules and their contents should not be cut, crushed, or chewed¹
• Can be taken with or without food¹

✓  Qelbree is prescribed once daily (AM or PM) for full 24-hour exposure^1,3
✓  Qelbree can be conveniently prescribed and refilled without a new prescription every month
✓  Qelbree has no known addiction potential or evidence of abuse^1,4,5
 

 
Qelbree is available in 3 capsule strengths¹      

IMPORTANT SAFETY INFORMATION

• Severe renal impairment: Initiate Qelbree at 100 mg once daily and increase by 50 mg to 100 mg at weekly intervals to a maximum recommended dosage of 200 mg once daily
   

Please see full Important Safety Information to the top left.

Please see full Prescribing Information, including Boxed Warning. 

Learn more about Qelbree, an extended-release, nonstimulant medication for ADHD: https://www.QelbreeHCP.com/

 
References: 

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc. 
2. Data on file, Supernus Pharmaceuticals.
3. Yanagita T, Wakasa Y, Kiyohara H. Drug dependence potential of viloxazine hydrochloride tested in rhesus monkeys. Pharmacol Biochem Behav. 1980;12:155-161.
4. Food and Drug Administration. Table of Prescription Stimulant Label Changes. May 10, 2023. Accessed July 13, 2023. https://www.fda.gov/media/168050/download

QBE.2023-0472