Fenfluramine Gets Priority Review for Lennox-Gastaut Syndrome
The sNDA submission is supported by data from a phase 3 trial that compared the efficacy and safety of fenfluramine with placebo in 263 patients aged 2 to 35 years with LGS.
Seizure Disorders
Sterility Issue Prompts Recall of Injectable Antiepileptic Drug
The recalled lots of Levetiracetam Injection 500mg per 5mL; NDC Number 25021-780-05, were distributed nationwide from March to November 2021.
Eprontia Oral Solution Approved for Partial-Onset, Primary Generalized Tonic-Clonic Seizures
Eprontia is approved for the treatment of partial-onset or primary generalized tonic-clonic seizures and migraine prevention.
Use of Enzyme-Inducing Antiseizure Meds May Up Long-Term CVD Risk
Increase in risk for incident cardiovascular disease reaches clinical significance approximately 10 years from first exposure
Levetiracetam Well Tolerated for Alzheimer Disease
Does not improve primary outcome, but did improve performance on certain cognitive tasks in those with epileptiform activity
Ganaxolone Gets Priority Review for CDKL5 Deficiency Disorder
The application is supported by data from the phase 3 Marigold study.
Briviact Approval Expanded to Include Younger Patients with Partial-Onset Seizures
Briviact is now indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Evidence to Support Suicidality Warning for Newer Antiseizure Meds Lacking
The analysis included 5 antiseizure medications (eslicarbazepine, perampanel, brivaracetam, cannabidiol, and cenobamate) evaluated in 17 randomized clinical trials.
Lithium Compared With Newer Therapies as Adjunct to Antidepressants
The likelihood of help or harm, also known as the risk/benefit ratio, was found to be more favorable for lithium.
Buccal Film Formulation of Diazepam to Get FDA Review
Libervant is a buccally administered soluble film of diazepam.
