The FDA has granted Zogenix Inc. breakthrough therapy designation for low-dose fenfluramine use to treat seizures related to Dravet syndrome, according to a press release issued by the company.
“We are very pleased that the FDA has granted breakthrough therapy designation based on the efficacy and safety results from Study 1 reported in the fall of 2017,” Gail M. Farfel, PhD, chief development officer of Zogenix, said in the release. “We look forward to working closely with the FDA as we conclude our phase 3 clinical program in Dravet syndrome, a rare and catastrophic form of childhood epilepsy.
ZX008 can also be used for the treatment of Lennox-Gastaut syndrome, according to the release This form of epilepsy is also severe and begins in childhood. Those who have this condition are likely to also have intellectual disability.