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.
An investigational transdermal cannabidiol gel was well-tolerated and consistently effective for adults with focal epilepsy.
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.
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.
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.
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).
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.
Safety data for Fycompa was consistent with the safety profile in adult populations without the need for weight-based dosing.
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.
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.