New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
July 9, 2014
08:33 EDTZGNXZogenix reports positive development on U.S. District Court ruling
Zogenix commented on the order issued by the U.S. District Court in Massachusetts upholding its prior decision that imposing regulations to restrict access to Zohydro ER Extended-Release Capsules, CII, violates Constitutional law. The court's decision supports the importance of upholding the principle at the heart of this case, which is that the FDA is the only regulatory body that is authorized to determine the approval and access of medicines for all Americans. On October 25, 2013, the FDA approved Zohydro ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, and today's decision preserves access for those in Massachusetts who may benefit from its medical attributes and sets a precedent for other states seeking to unjustly restrict access to Zohydro ER. Zogenix will continue to work to ensure patients have access to Zohydro ER in every state in a manner that is consistent with all extended-release opioids.
News For ZGNX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
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.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use