Seizure Disorders

Oxtellar XR Gains Monotherapy Indication for Partial-Onset Seizures

By December 17, 2018

Supernus announced that the FDA has approved the supplemental New Drug Application for Oxtellar XR (oxcarbazepine) to include monotherapy use for the treatment of partial-onset seizures patients aged ≥6 years.

Transdermal Cannabidiol Gel Well-Tolerated in Adults With Focal Epilepsy

By December 06, 2018

An investigational transdermal cannabidiol gel was well-tolerated and consistently effective for adults with focal epilepsy.

Should Antiepileptic Serum Concentrations Be Monitored More Frequently in Pregnancy?

December 06, 2018

Investigators observed that in pregnant women with epilepsy, the body begins to rapidly metabolize lamotrigine and levetiracetam at week 16 causing a fluctuating pattern of serum drug concentration.

Oral Film Formulation of Clobazam Gets FDA Approval for LGS

By November 05, 2018

The product was first granted tentative approval by the FDA in September 2018, and is now the first oral film formulation of clobazam to be approved for the treatment of seizures associated with LGS.

Epidiolex Now Available to Treat Seizures Associated With LGS, Dravet Syndrome

By November 01, 2018

The Food and Drug Administration (FDA) approved the treatment in June 2018, making it the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, as well as the first treatment indicated for patients with Dravet syndrome.

Acetaminophen Can Reduce Recurrence of Febrile Seizures

October 09, 2018

Rectal acetaminophen use was the largest contributor to the prevention of FS recurrence during the same fever episode among the variables in the final multiple logistic regression analysis (odds ratio, 5.6; 95% confidence interval, 2.3 to 13.3).

Acetaminophen reduces febrile seizure recurrence in children within same fever episode

October 08, 2018

Rectal acetaminophen reduces rates of second febrile seizure in children during the course of the same febrile illness when given rectally soon after initial seizure.

Fycompa Approved for Younger Epilepsy Patients With Partial-Onset Seizures

By October 01, 2018

Safety data for Fycompa was consistent with the safety profile in adult populations without the need for weight-based dosing.

DEA Reschedules Marijuana-Based Drug Epidiolex

By September 27, 2018

Drugs with a Schedule V classification have proven medical use and low abuse potential.

NDA Submitted for Valtoco Nasal Spray to Treat Acute Repetitive Seizures

By September 25, 2018

The Company states that the NDA is supported by robust clinical trial data, including patients studies where more than 1600 seizures were treated with Valtoco nasal spray.

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.