Seizure Disorders

Sympazan Oral Film Granted Tentative Approval for Lennox-Gastaut Syndrome

By September 04, 2018

Clobazam is currently available as oral tablets and suspension under the trade name Onfi (Lundbeck).

Diacomit Approved for the Treatment of Dravet Syndrome

By August 21, 2018

Diacomit was evaluated in 2 multicenter, placebo-controlled, double-blind, randomized studies.

Pregabalin may increase the risk of death when coprescribed with opioids

August 21, 2018

Patients coprescribed opioids and pregabalin had significantly increased odds of opioid-related death compared to opioid prescription alone.

FDA to Review Midazolam Nasal Spray for Seizure Clusters

By August 14, 2018

The NDA includes data from the Phase 3 ARTEMIS 1 trial which evaluated the intranasal spray in 292 patients.

New Formulation of Status Epilepticus Treatment To Be Reviewed

By July 31, 2018

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.

Modifiable Midlife Risk Factors Linked to Late-Onset Epilepsy

July 25, 2018

"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.

Evidence for Clobazam Monotherapy Use in Focal, Generalized Seizures Reviewed

By July 17, 2018

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.

Vigadrone Available for Refractory Complex Partial Seizures, Infantile Spasms

By July 16, 2018

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

Next-Generation Sequencing May Improve Pediatric Epilepsy Tx

June 29, 2018

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.

First Marijuana-Based Drug Approved to Treat LGS, Dravet Syndrome

By June 25, 2018

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.

Fycompa Granted Priority Review for Pediatric Indications

By May 30, 2018

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.

Addition of Cannabidiol May Cut Drop Seizures in Lennox-Gastaut

May 17, 2018

"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.

Briviact Approved for Pediatric Patients With Partial-Onset Seizures

By May 14, 2018

The expanded approval was supported by extrapolated efficacy data from placebo-controlled studies in adults with partial-onset seizures.

Lyrica Approved as Adjunctive Tx for Partial Onset Seizures in Children

By May 07, 2018

The approval was based on a 12-week, double-blind, placebo-controlled study (N=295) in pediatric patients 4-17 years of age.

FDA Approves Deep Brain Stimulation Therapy for Refractory Epilepsy

By May 02, 2018

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).

FDA: Lamotrigine Linked to Potentially Life-Threatening Adverse Reaction

By April 25, 2018

Clinicians should conduct a medical evaluation as soon as suspicious symptoms are reported and discontinue lamotrigine if HLH is suspected.

Too Few Adults Taking Epilepsy Meds Have Seizure Control

April 23, 2018

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.

FDA Committee Votes in Favor of Cannabidiol Oral Solution for LGS, Dravet Syndrome

By April 20, 2018

Epidiolex added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.

Afinitor Disperz Approved to Treat TSC-Associated Partial-Onset Seizures

By April 11, 2018

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.

Early-Life Epilepsy Should Be Urgently Treated With EBM

April 05, 2018

"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.

Fycompa sNDA Submitted for Pediatric Seizure Indications

By March 30, 2018

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.

Educational Attainment Down With In Utero Exposure to AEDs

March 27, 2018

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.

Adjuvant Cannabidiol Examined for Seizure Reduction in Pediatric-Onset Epilepsy

March 07, 2018

Researchers found for one person using CBD to experience a 50% or greater seizure reduction, the number needed to treat was 8.

Prenatal Valproate Exposure May Impact Offspring School Performance

February 21, 2018

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) .

Influenza vaccine not associated with increased risk of epilepsy in children

February 15, 2018

No increased risk of incident epilepsy was seen among children who received influenza vaccination during the 2009-2010 influenza season in Norway.

FDA Clears Smart Watch for Epilepsy Management

By February 06, 2018

Embrace uses advanced machine learning to monitor for grand mal or generalized tonic-clonic seizures, and sends an alert to summon caregivers' help.

Cannabidiol Effective for Treatment-Resistant Lennox-Gastaut Syndrome

January 25, 2018

"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.

Impact of Maternal Folate Status on Child's Autistic Traits After AED Exposure

By December 28, 2017

Children exposed to antiepileptic drugs (AEDs) in utero may have a reduced risk of autistic traits with periconceptional folic acid supplementation and folate status

More Than a Third of Patients Do Not Respond to Antiepileptics

December 28, 2017

Overall, 89.9% of patients who achieve seizure control do so with first, second AED regimen

Epidiolex Under Review for Two Childhood-Onset Epilepsy Conditions

By December 28, 2017

Epidiolex is a pharmaceutical formulation of purified cannabidiol