Qelbree From Supernus Pharmaceuticals, Inc

The FDA has approved Qelbree (viloxazine extended-release capsules; Supernus Pharmaceuticals, Inc) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 to 17 years.¹

ADHD is one of the most common mental health conditions in the United States. Qelbree is a nonscheduled, nonstimulant medication.²

Pharmacology and Pharmacokinetics

Qelbree is a selective norepinephrine reuptake inhibitor. Its mechanism of action in the treatment of ADHD remains unclear.

Qelbree reaches steady-state plasma concentration after 2 days of once-daily oral administration. The median time to peak plasma concentration is approximately 5 hours, with a range of 3 to 9 hours, after a single dose of 200 mg. Qelbree is mainly metabolized by CYP2D6, UGT1A9, and UGT2B15. It displays a mean elimination half-life of approximately 7 hours. Its primary route of excretion is renal.¹

Dosage and Administration

The recommended starting dose of Qelbree for patients aged 6 to 11 years is 100 mg orally, once daily. The dose may be titrated in 100-mg increments at weekly intervals to the maximum recommended dose of 400 mg, once daily. Patients aged 12 to 17 years should begin treatment with 200 mg orally, once daily. The dose may be increased by 200 mg after 1 week of treatment to the maximum recommended dose of 400 mg, once daily. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m2) should begin treatment with 100 mg, once daily, with titrations in 50-mg to 100-mg increments at weekly intervals to the maximum recommended dose of 200 mg, once daily. A dose adjustment is not required for patients with mild to moderate renal impairment (eGFR, 30-89 mL/min/1.73m2). Dose titrations should be based on patient response and tolerability.

Qelbree may be taken with or without food. The capsule may be swallowed whole or opened and sprinkled entirely onto a teaspoonful of applesauce, which should be completely consumed without chewing within 2 hours. The capsules should not be chewed, crushed, or cut.¹

Clinical Trials

Qelbree was evaluated for efficacy in the treatment of ADHD in 3 double-blind, multicenter, parallel group, placebo-controlled, randomized, short-term monotherapy trials of pediatric patients aged 6 to 17 years with ADHD. Study 1 consisted of participants aged 6 to 11 years. After a 1-week titration period, participants received once-daily Qelbree 100 mg or 200 mg or a placebo for the 5-week maintenance phase. Study 2 consisted of participants aged 6 to 11 years. After a 3-week titration period, participants received once-daily Qelbree 200 mg or 400 mg or a placebo for the 5-week maintenance phase. Study 3 consisted of participants aged 12 to 17 years. After a 1-week titration period, participants received once-daily Qelbree 200 mg or 400 mg or a placebo for the 5-week maintenance phase.

The primary end point of each study was the change from baseline in the total score on the ADHD Rating Scale 5 (ADHD-RS-5), which assesses symptoms of hyperactivity, impulsivity, and inattentiveness. A secondary end point was the Clinical Global Impression-Improvement (CGI-I) score. Each study found a statistically significant greater reduction in the ADHD-RS-5 total score and CGI-I score in the participants who received either dose of Qelbree versus those participants who received the placebo.¹

Contraindications, Warnings, and Precautions

Qelbree carries a boxed warning stating that higher rates of suicidal behaviors and thoughts were reported in pediatric patients with ADHD who were using Qelbree than in those who received a placebo. All patients using Qelbree should be closely monitored for clinical worsening and for the emergence of suicidal behaviors and thoughts.

Concomitant administration of Qelbree with monoamine oxidase inhibitors (MAOI) or the use of Qelbree within 14 days after discontinuing an MAOI is contraindicated. Concomitant use of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range with Qelbree is also contraindicated.

Blood pressure and heart rate should be assessed prior to beginning treatment, following each dose increase, and periodically thereafter. Patients should be screened for bipolar disorder before beginning the medication. Caution is advised when driving or operating hazardous machinery because of the potential for fatigue, lethargy, sedation, and somnolence while using Qelbree. Qelbree should not be using during pregnancy or in patients with hepatic impairment.

The most common adverse reactions were decreased appetite, fatigue, insomnia, irritability, nausea, somnolence, and vomiting.¹

Monica Holmberg, PharmD, BCPS, is a pharmacist and Pharmacy Times contributor.

REFERENCES

1. Qelbree. Prescribing information. Supernus Pharmaceuticals Inc; 2021. Accessed April 27, 2021. https://www.supernus.com/sites/default/files/Qelbree-Prescribing-Info.pdf

2. Supernus announces FDA approval of Qelbree (SPN-812) for the treatment of ADHD. News release. Supernus Pharmaceuticals Inc. April 2, 2021. Accessed April 27, 2021. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-qelbreetm-spn-812-treatment-adhd