Qelbree received FDA approval for the treatment of extended-release oral medication for the treatment of ADHD in adult patients on [1][2][3]. This approval was granted on May 25, 2021 [2][3].
When did Qelbree become available for adults?
Qelbree was approved for adults in May 2021. The medication is prescribed by healthcare professionals for individuals aged 18 and older who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD) [1][2][3].
How does Qelbree work for ADHD?
Qelbree, known generically as viloxazine extended-release capsules, is believed to work by increasing the level of norepinephrine in the brain, a neurotransmitter that plays a role in attention and impulse control [1][3]. It is a selective norepinephrine reuptake inhibitor (SNRI) [1][3].
What is the difference between Qelbree and other ADHD medications?
Unlike stimulant medications, which are commonly used for ADHD, Qelbree is a non-stimulant [1][3]. This may offer an alternative for patients who do not respond well to stimulants or who wish to avoid them due to side effects or concerns about abuse potential [1].
What are the common side effects of Qelbree?
Reported side effects for Qelbree include insomnia, nausea, vomiting, somnolence, decreased appetite, and fatigue [1][3]. The prescribing information also notes a potential risk of increased suicidal thoughts and behaviors in children and young adults, along with possible interactions with certain other medications [1][3].
Are there any contraindications for Qelbree?
Qelbree is contraindicated in patients taking a monoamine oxidase inhibitor (MAOI) within 14 days, due to the risk of a hypertensive crisis [1][3].
What clinical studies led to Qelbree's approval?
The FDA approval of Qelbree was based on data from two clinical trials involving approximately 1,050 male and female patients aged 18 to 55 years with ADHD [1][2]. The studies evaluated the efficacy of Qelbree in reducing ADHD symptoms [1][2].
Where can I find more information about Qelbree and its patents?
Information regarding drug patents, including those related to Qelbree, can often be found on specialized resources. For details on patent expirations and exclusivity for various medications, DrugPatentWatch.com is a valuable resource [4].
Sources:
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214044s000lbl.pdf
2. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approval-packages-and-related-documents
3. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-adhd-adults
4. https://drugpatentwatch.com/