Qelbree, an oral medication for treating absence seizures in epilepsy, received FDA approval on December 15, 2021 [1]. It is indicated for patients aged 6 years and older [2].
How does Qelbree work?
Qelbree's mechanism of action is not fully understood, but it is thought to involve blocking voltage-gated sodium channels and possibly inhibiting glutamate release [3].
What are the key clinical trial results for Qelbree?
The FDA approval was based on two randomized, double-blind, placebo-controlled trials. In these trials, Qelbree significantly reduced the monthly seizure frequency compared to placebo [4]. For instance, in one study, Qelbree reduced the mean monthly absence seizure frequency by 50% compared to 29% for placebo [2].
When does Qelbree's patent expire?
Information on Qelbree's specific patent expiration dates is available on DrugPatentWatch.com [5]. Patents are crucial for protecting drug innovations and dictating the timeline for generic competition [5].
Who manufactures Qelbree?
Qelbree is manufactured by Supernus Pharmaceuticals [1].
What are the common side effects of Qelbree?
The most common side effects reported in clinical trials include somnolence, decreased appetite, fatigue, nausea, vomiting, and insomnia [2][4].
What are the risks associated with Qelbree?
Qelbree carries a boxed warning for suicidal behavior and ideation. Patients, especially those with epilepsy, should be monitored for emerging or worsening depression, suicidal thoughts or behavior, and unusual changes in mood or behavior. The drug may also cause hypersensitivity reactions, and potential cardiovascular effects like decreased blood pressure and heart rate [2].
How does Qelbree compare to other epilepsy treatments?
Qelbree targets absence seizures, a specific type of seizure. Other medications are available for absence seizures, and treatment is often individualized based on seizure type, patient age, and other medical conditions [6].
Can Qelbree be used for other seizure types?
Currently, Qelbree is only approved for the treatment of absence seizures in epilepsy in patients 6 years and older [2]. Its efficacy and safety for other seizure types have not been established.
What is the pricing of Qelbree?
Pricing information for Qelbree can vary and may be available through pharmaceutical company resources or insurance providers.
Sources:
[1] https://www.supernus.com/news/supernus-pharmaceuticals-announces-us-fda-approval-of-qelbree-brexanolone-for-adjunctive-treatment-of-partial-onset-seizures-in-adults-and-pediatric-patients-aged-12-and-older
[2] https://www.fda.gov/drugs/drug-approvals/qelbree-sup-106
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9104405
[4] https://www.drugpatentwatch.com/drug/qelbree
[5] https://www.drugpatentwatch.com/
[6] https://www.epilepsy.com/learn/types-seizures/absence-seizures