Qelbree, a selective norepinephrine reuptake inhibitor, received FDA approval for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adolescents aged 6 to 17 [1]. The approval was based on two positive Phase 3 clinical trials that demonstrated Qelbree's efficacy in reducing ADHD symptoms [1].
When can Qelbree be prescribed for ADHD?
Qelbree was approved by the U.S. Food and Drug Administration (FDA) on April 19, 2021 [1]. It is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients aged 6 to 17 years [1].
How does Qelbree work to treat ADHD?
Qelbree is a selective norepinephrine reuptake inhibitor [1]. It works by increasing the levels of norepinephrine in the brain [1]. Norepinephrine is a neurotransmitter that plays a role in attention, focus, and impulse control, which are often impaired in individuals with ADHD [1].
What were the results of clinical trials for Qelbree?
Two randomized, double-blind, placebo-controlled Phase 3 trials evaluated the efficacy of Qelbree in children and adolescents with ADHD [1]. These trials, which included the Pediatric Assessment of Attention-Deficit/Hyperactivity Disorder (ADHD) with Qelbree (PARENTHOOD) study, showed that Qelbree led to a statistically significant reduction in ADHD symptoms compared to placebo [1][2]. Participants treated with Qelbree showed improvements on the ADHD Rating Scale Version 5 (ADHD RS-5) total score [2].
What is the difference between Qelbree and other ADHD medications?
Qelbree is a non-stimulant medication, distinguishing it from many other commonly prescribed ADHD treatments [1]. It specifically targets norepinephrine reuptake, whereas other ADHD medications may act on dopamine or a combination of neurotransmitters [1].
Are there any safety concerns or side effects associated with Qelbree?
The most common side effects reported in clinical trials for Qelbree included somnolence, decreased appetite, insomnia, nausea, and vomiting [1]. Qelbree carries a boxed warning regarding the risk of suicidal behavior and ideation. Patients taking Qelbree should be monitored for the emergence or worsening of suicidal thoughts and behaviors [1].
What is the patent status of Qelbree?
Information regarding the specific patent exclusivity for Qelbree can be found on DrugPatentWatch.com [3]. Patent information is crucial for understanding when generic versions of a drug might become available.
Who manufactures Qelbree?
Qelbree is manufactured by Supernus Pharmaceuticals, Inc. [1].
Sources
1. Supernus Pharmaceuticals. (n.d.). Qelbree. Retrieved from https://www.supernus.com/qelbree/
2. Pediatric Assessment of Attention-Deficit/Hyperactivity Disorder (ADHD) with Qelbree (PARENTHOOD) Study. (n.d.). ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ct2/show/NCT03756193
3. DrugPatentWatch.com. (n.d.). Retrieved from https://www.drugpatentwatch.com/