General Information 

Qelbree (viloxazine extended-release capsules) is a selective norepinephrine reuptake inhibitor.

Qelbree is specifically indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

Qelbree is supplied as a capsule for oral administration. The recommended dose(s) is as follows:

• Pediatric patients 6 to 11 years of age: the recommended starting dosage for pediatric patients 6 to 11 years of age is 100 mg orally once daily. Dosage may be titrated in increments of 100 mg at weekly intervals to the maximum recommended dosage of 400 mg once daily, depending on response and tolerability.
• Pediatric patients 12 to 17 years of age: the recommended starting dosage for pediatric patients 12 to 17 years of age is 200 mg orally once daily. After 1 week, dosage may be titrated by an increment of 200 mg to the maximum recommended dosage of 400 mg once daily, depending on response and tolerability. Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of Qelbree and adjust dosage as needed.
• Adults 18 years of age and older: flexible dose of 200 mg to 600 mg

Administer Qelbree orally with or without food. Do not cut, crush, or chew the capsules. Swallow Qelbree capsules whole or open the capsule and sprinkle the entire contents over a teaspoonful of applesauce. Consume all the sprinkled applesauce in its entirety, without chewing, within 2 hours; do not store for future use.

Mechanism of Action

Qelbree (viloxazine extended-release capsules) is a selective norepinephrine reuptake inhibitor. The mechanism of action of viloxazine in the treatment of ADHD is unclear; however, it is thought to be through inhibiting the reuptake of norepinephrine.

Side Effects

Adverse effects associated with the use of Qelbree may include, but are not limited to, the following:

• somnolence
• decreased appetite
• fatigue
• nausea
• vomiting
• insomnia
• irritability

The Qelbree drug label comes with the following Black Box Warning: Suicidal Thoughts and Behaviors: In clinical trials, higher rates of suicidal thoughts and behavior were reported in pediatric patients treated with Qelbree than in patients treated with placebo. Closely monitor for worsening and emergence of suicidal thoughts and behaviors.

Clinical Trial Results

The FDA approval of Qelbree was based on three short-term, randomized, placebo-controlled monotherapy trials (Studies 1, 2, and 3).

Study 1 was a multicenter, randomized, double-blind, three-arm placebo-controlled, parallel group monotherapy trial in patients 6 to 11 years of age with ADHD. A total of 477 patients were randomized; 399 completed the study, and 78 discontinued. The duration of the trial was 6 weeks, including a 1-week titration period (starting at 100 mg once daily) and 5-week maintenance phase. Patients were randomized to receive 100 mg, 200 mg, or placebo, given once daily as a single dose. The primary endpoint was the change from baseline to the end of study on the total score on the ADHD Rating Scale (ADHD-RS-5), an 18- question scale that assesses hyperactivity, impulsivity, and inattentive symptoms. Higher ADHD-RS-5 scores reflect more severe symptoms. A key secondary endpoint was the Clinical Global Impression-Improvement (CGI-I) score at the end of the study. The change from baseline (reduction) in ADHD-RS-5 total score was statistically significantly greater in patients treated with Qelbree 100 mg or with Qelbree 200 mg than in patients on placebo. Compared with patients on placebo, a statistically significantly greater reduction (improvement) in CGI-I score at the end of the study was observed both in patients treated with Qelbree 100 mg and in patients treated with Qelbree 200 mg.

Study 2 was a multicenter, randomized, double-blind, three-arm, placebo-controlled, parallel group monotherapy trial in patients 6 to 11 years of age with ADHD. A total of 313 patients were randomized; 251 completed the study, and 62 discontinued. The duration of treatment was 8 weeks, including a 3-week titration period (starting at 100 mg once daily), and a 5-week maintenance phase. Patients were randomized to receive Qelbree 200 mg, Qelbree 400 mg, or placebo, given once daily as a single dose. The primary endpoint was the change from baseline to the end of study on the total score on the ADHD-RS-5. The CGI-I score at the end of the study was a secondary endpoint.  The change from baseline (reduction) in ADHD-RS-5 total score was statistically significantly greater in patients treated with Qelbree 200 mg or with Qelbree 400 mg than in patients on placebo. Compared with patients on placebo, a statistically significantly greater reduction (improvement) in CGI-I score at the end of the study was observed both in patients treated with Qelbree 200 mg and in patients treated with Qelbree 400 mg.

Study 3 was a multicenter, randomized, double-blind, three-arm, placebo-controlled, parallel group monotherapy trial in patients 12 to 17 years of age with ADHD. A total of 310 patients were randomized; 266 completed and 44 discontinued. Total duration of treatment was 6 weeks, including 1-week titration period (starting at 200mg once daily) and a 5-week maintenance phase. Patients were randomized to receive Qelbree 200 mg, Qelbree 400 mg, or placebo, given once daily as a single dose. The primary endpoint was the change from baseline to the end of study on the total score on the ADHD-RS-5. The CGI-I score at the end of the study was a secondary endpoint. The change from baseline (reduction) in ADHD-RS-5 total score was statistically significantly greater in patients treated with Qelbree 200 mg or with Qelbree 400 mg than in patients on placebo. Compared with patients on placebo, a statistically significantly greater reduction (improvement) in CGI-I score at the end of the study was observed both in patients treated with Qelbree 200 mg and in patients treated with Qelbree 400 mg.