Epilepsy

The framework consists of 2 documents that expand on the agency’s plans for its risk-based approach for describing drugs, devices, and biologics, including those designated as regenerative medicine advanced therapies.

Results of this Swedish study may help guide decisions about monitoring and induction of labor.

Despite accessibility to antiepileptic drugs in high-income settings, more than one-third of patients with newly diagnosed epilepsy were not treated or had delayed treatment.

The director of the Pediatric Epilepsy Center at UCSF Benioff Children’s Hospital discussed the efficacy profile of ZX008, for which Zogenix recently submitted a new drug application to the FDA for the treatment of Dravet syndrome.

The neurosurgeon at The Ohio State University Wexner Medical Center and lead investigator of the first-in-world trial spoke about the study’s goals and the potential of the treatment.

The executive vice president and chief medical officer of Zogenix spoke about what sets the fenfluramine agent apart and what clinicians need to know after its NDA submission.

Guidelines from the American Academy of Neurology now cover the use of third-generation antiepileptic drugs for patients with new-onset focal or generalized epilepsy.

The initial phase 2 studies of cenobamate evaluated close to 1000 individuals, with efficacy demonstrated to the point that the FDA did not require additional efficacy studies.

The NDA for Zogenix's fenfluramine therapy is supported by data from 2 phase 3 trials in Dravet syndrome, as well as an interim analysis from the company’s ongoing open-label extension study, which includes 232 patients treated for up to 21 months.

After a teenager spends 2 months in the ICU with refractory seizures, his family requests a trial of cannabidiol oil.

The recall began in October 2018, was initiated due to a mislabeling on the pre-printed content on the infusion bag for lot ABD807. Thus far, there have been no reported adverse events related to this recall.