SK Life Science Inc., a subsidiary of SK Biopharmaceuticals Co. Ltd. – an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders – will present data from a pooled analysis from studies C013/C017 OLEs and C021 evaluating the cognitive and psychiatric treatment-related adverse events during adjunctive treatment with anti-seizure medication XCOPRI® (cenobamate tablets) CV at the American Academy of Neurology Annual Meeting, held in-person in Seattle April 2–7, 2022.
UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.
The U.S. health regulator approved Marinus Pharmaceuticals Inc.’s lead drug to treat seizures associated with a rare genetic disorder in patients two years of age and older, the company said on March 18, sending its shares soaring around 36 percent.
In a paper published in Alzheimer’s and Dementia, a team of researchers called for more prospective studies that will look into the impact COVID-19 has on brain functioning, given the disease has been frequently associated with neurologic symptoms such as seizures and psychosis.
While the world has largely been focused on the development of vaccines and therapeutics for Covid-19, the U.S. Food and Drug Administration has remained busy lining up potential approvals of medications for other diseases and illnesses.
The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.
The U.S. Food and Drug Administration approved Zogenix Inc.’s Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
Neurelis Inc. announced the commercial availability of Valtoco (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
The U.S. Food and Drug Administration accepted Aquestive Therapeutics’ New Drug Application for Libervant (diazepam) Buccal Film for seizure clusters.