Patients coprescribed opioids and pregabalin had significantly increased odds of opioid-related death compared to opioid prescription alone.
The product is being reviewed as a treatment for generalized tonic-clonic status epilepticus, for the prevention and treatment of seizures occurring during neurosurgery, as a short-term substitute for oral phenytoin, when oral administration is not possible, and for pediatric use.
"Although stroke and dementia were both associated with late-onset epilepsy, vascular and lifestyle risk factors were significant even in the absence of stroke or dementia," the authors write.
Researchers searched various databases to identify trials that compared clobazam monotherapy to placebo or another antiepileptic drug in patients with ≥2 unprovoked seizures or a single acute symptomatic seizure requiring short-term continuous treatment.
Like Sabril, Vigadrone carries a Boxed Warning regarding the risk of permanent vision loss and is only available to healthcare professionals and patients under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program
By testing type, detection rates were 32.6% for the epilepsy-related gene panel, 44.8% for the clinical WES gene panel, and 17.3% for WES.
This marks the first approved drug that contains an active ingredient derived from marijuana as well as the first treatment approved for patients with Dravet syndrome.
The sNDA included data from Study 311 (N=180), an ongoing, open-label, multicenter trial with an extension phase that evaluated the safety, tolerability, and exposure-efficacy relationship of Fycompa oral suspension as adjunctive therapy in children (4 to 11 years) with inadequately controlled POS or PGTC seizures.
"The addition of cannabidiol at a dose of 10mg or 20mg per kilogram per day to a conventional antiepileptic regimen resulted in greater reductions in the frequency of drop seizures than placebo," the authors write.
The expanded approval was supported by extrapolated efficacy data from placebo-controlled studies in adults with partial-onset seizures.
The approval was based on a 12-week, double-blind, placebo-controlled study (N=295) in pediatric patients 4-17 years of age.
The approval is specifically for bilateral anterior thalamic nucleus stimulation and is based on results from the SANTE study (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy).
Clinicians should conduct a medical evaluation as soon as suspicious symptoms are reported and discontinue lamotrigine if HLH is suspected.
Only 44% of those taking epilepsy medication reported having their seizures controlled. There were correlations for higher prevalence of active epilepsy and poorer seizure control with low family income; unemployment; and being divorced, separated, or widowed.
Epidiolex added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
The approval was based on the Phase 3, randomized, double-blind, placebo-controlled EXIST-3 (EXamining everolimus In a Study of TSC) study which evaluated adjunctive Afinitor Disperz (low exposure: 3-7ng/mL; high exposure: 9-15ng/mL) in patients with treatment-resistant TSC-associated partial-onset seizures, defined as inadequate control of partial-onset seizures despite use of ≥2 sequential regimens of single or combined anti-epileptic drugs.
"Epilepsies in infants and young children should be treated with the urgency that we see in pediatric oncology," said Anne T. Berg, PhD from the Ann & Robert H. Lurie Children's Hospital of Chicago, who authored the article.
The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years.
The researchers found that fewer children with mothers being prescribed sodium valproate during pregnancy achieved the national minimum standard in the core subject indictor (CSI), mathematics, language, and science.
Researchers found for one person using CBD to experience a 50% or greater seizure reduction, the number needed to treat was 8.
The researchers found that children exposed to valproate scored worse on the sixth-grade Danish tests (adjusted difference, −0.27 standard deviation [SD]) and sixth-grade mathematics tests (adjusted difference, − 0.33 SD) .
No increased risk of incident epilepsy was seen among children who received influenza vaccination during the 2009-2010 influenza season in Norway.
Embrace uses advanced machine learning to monitor for grand mal or generalized tonic-clonic seizures, and sends an alert to summon caregivers' help.
"Add-on cannabidiol is efficacious for the treatment of patients with drop seizures associated with Lennox-Gastaut syndrome and is generally well tolerated," the authors write.
Children exposed to antiepileptic drugs (AEDs) in utero may have a reduced risk of autistic traits with periconceptional folic acid supplementation and folate status