Safety data for Fycompa was consistent with the safety profile in adult populations without the need for weight-based dosing.
Drugs with a Schedule V classification have proven medical use and low abuse potential.
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.
The odds of language delay were lower at 18 months and 36 months in children exposed to AEDs in utero whose mothers took folic acid.
This widespread variation in strategies may contribute to undesirable outcomes that are characterized by poor seizure control and added deficits.
Although 2 patients experienced an increase in seizure frequency, the remaining patients did not experience a change in frequency.
Countable seizure types were recorded in parents' and caregivers' clinical diaries during a 4-week baseline period.
The investigators sought to detect whether neuroimaging during an emergency department visit was associated with acute changes in the management of patients.
The risk for late-onset epilepsy was lower in patients with higher physical activity levels and moderate alcohol intake.
Recurrence of seizures was reported in 28.2% of patients who attempted withdrawal.
Clobazam is currently available as oral tablets and suspension under the trade name Onfi (Lundbeck).
Approximately 78% of treated patients experienced at least 1 treatment-related adverse event.
The findings offer some reassurance for clinicians and for pregnant women who are successfully treated with enzyme-inducing ACDs.
Diacomit was evaluated in 2 multicenter, placebo-controlled, double-blind, randomized studies.
The results of this review are applicable primarily to persons with focal onset seizures, with 88% of included participants experiencing this type of seizure at baseline.
Investigators assessed demographic and epilepsy-specific factors independently associated with anxiety, including lesions and seizure focus localization.
An expert subcommittee was formed consisting of members of the AAN and AES to update the 2004 evidence-based guidelines on epilepsy treatment with AEDs.
Studies that have evaluated the use of VNS in children, including those as young as 6 months old, and have generally concluded that it is well tolerated and improves quality of life.
Seizures are often associated with accumulation of extracellular glutamate due to the synchronous discharges of excitatory neurons.
The NDA for IM/IV Captisol-Enabled Fosphenytoin has been accepted for review and given a Prescription Drug Fee User Act date, by the FDA.
Potentially modifiable risk factors in midlife are associated with the risk of developing late-onset epilepsy.
Cognitive and linguistic deficits have been cited as risk factors for psychiatric comorbidity in pediatric epilepsy, along with family factors such as parenting style and quality of the parent-child relationship.
Claims data spanning 4 years were obtained from a pediatric accountable care organization.
The safety and efficacy of clobazam monotherapy in patients with new-onset focal or generalized seizures was investigated in a new Cochrane systematic review.
The efficacy was reported to be significantly higher in patients who had taken benzodiazepines.
Causes of death in patients with epilepsy were assessed to determine the presence of cardiac pathology.
The FDA has approved an abbreviated New Drug Application for Vigadrone, the generic alternative to Sabril powder for oral solution.
Investigators sought to examine whether seizures are capable of causing changes in serotonin levels in the peripheral circulation.
Next-generation sequencing can improve treatment efficacy and reduce hospitalization in children with drug-resistant epilepsy.
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.
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