Zogenix's Dravet Syndrome Treatment Returns 'Strong' Results

Zogenix's Dravet Syndrome Treatment Returns 'Strong' Results”

Patients taking ZX008 0.2 mg/kg/day also showed a reduction in mean monthly convulsive seizures of 33.7% compared to placebo (P =.019). ZX008 has received orphan drug designation in the United States and European Union (EU), for the treatment of Dravet syndrome. The biotech hopes to win approval for its formulation of the drug in both the USA and Europe.

Not only did Zogenix nail its primary endpoint, but ZX008 also demonstrated statistically significant improvements versus the placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval. Epidiolex is an oral drug created from plant-derived cannabidiol. For comparison, only 2.5% of patients in the placebo group achieved that level of benefit. Patients treated with Fen-Phen were found to be at greater risk of developing heart problems, including pulmonary hypertension.

Patients in the study were randomized to either a 0.8 mg/kg daily dose of ZX008, a 0.2 mg/kg daily dose or placebo. You might remember fenfluramine as part of the "fen-phen" obesity regimen that was pulled from the market in 1997 because fenfluramine (at a higher dose) caused severe damage to people's heart valves.

"Dravet syndrome is a rare, but catastrophic form of epilepsy that can be devastating for patients and their families", Joseph Sullivan, MD, director of the Pediatric Epilepsy Center in UCSF Benioff Children's Hospital San Francisco, and principal investigator of Study 1 in the U.S., said in a statement.

Details of the adverse events have not been provided by the company but they did note that the drug was generally well tolerated with the incidence of serious adverse events was similar in the 3 treatment groups [12.5% (n=5) in the 0.8 mg/kg/day group; 10.3% (n=4) in the 0.2 mg/kg/day group; and 10.0% (n=4) in the placebo group].

David and Tom just revealed what they believe are the 10 best stocks for investors to buy right now. and Zogenix wasn't one of them!

Management will host a conference call this morning at 8:30 am ET to discuss the results.

Additionally, an FDA filing for approval of ZX008 won't happen until a second Dravet syndrome confirms efficacy.

Based in Emeryville, California, the pharmaceutical company expects results from a second trial in the first half of next year. More than 25,644,298 shares have changed hands.

When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. His clients may have positions in the companies mentioned. The Motley Fool has a disclosure policy.

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