Zogenix Announces Receipt of FDA Breakthrough Therapy Designation for ZX008 in Dravet Syndrome

Zogenix (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational product, ZX008 (low-dose fenfluramine), for the treatment of seizures associated with Dravet syndrome.

As quoted in the press release:

“We are very pleased that the FDA has granted Breakthrough Therapy Designation based on the efficacy and safety results from Study 1 reported in fall of 2017,” said Gail M. Farfel, Ph.D., Chief Development Officer of Zogenix.  “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.”

Click here to read the full press release.