Brexanolone Safe, Tolerable as Adjunctive Therapy in Super-Refractory Status Epilepticus
Within 5 days of initiating brexanolone infusion, 16 patients were successfully weaned off TLAs without anesthetic agent reinstatement.
HealthDay News — For patients with super-refractory status epilepticus (SRSE), brexanolone as adjunctive therapy is tolerated and associated with a high rate of third-line agent (TLA) weaning, according to a study published in the Annals of Neurology.
Eric S. Rosenthal, MD, from Massachusetts General Hospital in Boston, and colleagues conducted a multi-center study involving 25 SRSE patients to examine the safety and tolerability of brexanolone. Patients receiving TLAs for SRSE control were eligible for brexanolone loading infusions followed by maintenance infusion. TLAs were weaned during brexanolone maintenance after 48 hours of infusion. Brexanolone dose was tapered after 4 days.
The researchers noted no serious adverse events (SAEs) attributed to the study drug. Overall, 16 patients experienced 1 or more SAEs. There were 6 deaths, which were all related to underlying medical conditions. Twenty-two patients underwent 1 or more attempts at TLA weaning.
The response end point of weaning successfully off TLAs before tapering brexanolone was met by 17 patients (77%). Within 5 days of initiating brexanolone infusion, 16 patients were successfully weaned off TLAs without anesthetic agent reinstatement in the following 24 hours.
"The results suggest the possible development of brexanolone as an adjunctive therapy for SRSE requiring pharmacologic coma for seizure control," the authors wrote.
Disclosures: Several authors disclosed financial ties to pharmaceutical companies, including Sage Therapeutics, which manufactures brexanolone and funded the study.
Rosenthal ES, Claassen J, Wainwright MS, et al. Brexanolone as adjunctive therapy in super-refractory status epilepticus [published online August 5, 2017]. Ann Neurol. doi:10.1002/ana.25008o