Zogenix was undone by attaching the wrong document

Zogenix’s plan to win approval for a new epilepsy drug always came with risks. The therapy, ZX008, uses a formulation of fenfluramine, which, you may recall, was one half of the anti-obesity treatment “fen-phen” that got pulled off the market in the 1990s due to serious cardiac side effects.

But yesterday, when Zogenix revealed that the FDA had refused to even consider ZX008, the reason had nothing to do with that. Instead, according to the company, the application was missing some animal data on chronic dosing and “contained an incorrect version of a clinical dataset, which prevented the completion of the review process.”

The first thing is arguably more alarming, as it means Zogenix might have to conduct additional preclinical research. But the second is more novel. Drug companies spend untold hours and dollars crossing the t’s and dotting the i’s of FDA applications. How does one end up submitting the wrong version?

In a statement, Zogenix said it remains “highly confident” in ZX008’s efficacy and is “fully committed to working with the FDA” to get all this resolved.