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December 7, 2012
17:49 EDTZGNXZogenix announces FDA panel votes against approval of Zohydro ER
Zogenix announced that the U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee voted 2-11 against the approval of Zohydro ER, an extended-release formulation of hydrocodone without acetaminophen, for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. "We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population," Zogenix COO Stephen Farr said. The Prescription Drug User Fee Act date for completion of FDA review of the Zohydro ER New Drug Application for approval is March 1, 2013.
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May 27, 2015
08:44 EDTZGNXZogenix announces new efficacy data from study of low-dose fenfluramine
Zogenix announced new data demonstrating sustained efficacy and tolerability for patients treated with low-dose fenfluramine as an adjunctive therapy for Dravet syndrome. The data was authored by world-renown experts in the field of Dravet syndrome, Berten Ceulemans, M.D., Ph.D. and Lieven Lagae, M.D., Ph.D., from the Universities of Antwerp and Leuven in Belgium, and was presented at the European Paediatric Neurology Society meeting taking place this week in Vienna, Austria. Zogenix intends to initiate Phase 3 clinical studies for ZX008, the company's investigational proprietary pediatric formulation of low-dose fenfluramine, during the second half of 2015. ZX008 is designated as an orphan drug in both the U.S. and Europe for the treatment of Dravet syndrome. The results presented are from the latest 5-year follow-up period in a group of Dravet syndrome patients being treated with low-dose fenfluramine. This analysis, which includes ten patients from the original study group and two patients who began treatment in 2011, demonstrated that during any given year of the follow-up period, at least 80% of patients achieved a greater than or equal to 75% reduction in the frequency of seizures. In addition, three patients were seizure-free for all 5 years and five patients were seizure-free for 2 to 4 years. The use of low-dose fenfluramine in this group of patients was shown to be generally well tolerated, with the most common adverse events being transient loss of appetite and fatigue/somnolence. No clinically meaningful cardiac adverse events were noted. No patient discontinued treatment due to adverse events. In addition, a recently published translational research study to elucidate fenfluramine's mechanism of action in Dravet syndrome demonstrated the ability of fenfluramine to significantly reduce locomotion and eliminate epileptiform EEG activity in a gene knockdown zebrafish model of Dravet syndrome. These data support the clinical results obtained in the Belgium cohort of patients.

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