Seems that there’s trouble up at t’ut mill for GW as new drug “Zogenix” challenges “Epidiolex” on fits & seizures.
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Last week, small-cap biotech Zogenix (NASDAQ:ZGNX) shocked Wall Street and investors by unveiling phase 3 data on its investigational drug for Dravet syndrome, low-dose fenfluramine hydrochloride, which is referred to as fenfluramine for short. The study not only met its primary endpoint of a statistically significant reduction in seizure frequency relative to the placebo, but it would appear to have run circles around Epidiolex in a similar grouping of patients — albeit the two drugs haven’t gone head-to-head in a study.
Back in March 2016, GW Pharmaceuticals reported that Epidiolex had reduced seizure frequency by 39% in Dravet syndrome patients as compared to 13% for the placebo from baseline. The baseline was determined by following patients for four weeks prior to trial start, and the study lasted 14 weeks.
By comparison, Zogenix’s fenfluramine delivered a superior 72.4% reduction in convulsive seizure frequency compared to 17.4% for placebo patients over the 14-week treatment period. One minor difference was that Zogenix took six weeks to establish its baseline instead of four. On the surface, and while doing a bit of an apples-to-oranges comparison, Zogenix’s lead drug looks like a serious threat to GW’s top experimental compound.
As noted by Janney analyst Ken Trbovich via Investor’s Business Daily, “We believe investors previously ignored the threat from Zogenix because its program was only supported by a small (12 patients), open-label study conducted in Europe.”
It’s worth noting that Zogenix is also studying fenfluramine as a treatment for Lennox-Gastaut syndrome.
But as they say on the late night ads.. “but wait that’s not all”
More issues for Epidiolex than meets the eye
That’s not necessarily the only blow for GW Pharmaceuticals. In the company’s third-quarter earnings release was an announcement that it had delayed its new drug application (NDA) filing in the U.S. for Epidiolex until October from mid-2017. A first-in-class drug would have an opportunity to gobble up market share with no approved indications, but Epidiolex’s possible approval by the Food and Drug Administration (FDA) has now been pushed back a few months.
Also, there are no guarantees that Epidiolex can even beat fenfluramine, which is expected to have an NDA filed by Zogenix in the second half of 2018, to pharmacy shelves. Because Epidiolex is derived from cannabinoids, and there’s no precedence for cannabinoid-based drugs on the market, it’s likely the FDA will take its time with approving a marketing label, and that the U.S. Drug Enforcement Agency (DEA) will need to schedule Epidiolex before it makes it onto pharmacy shelves, assuming approval.