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July 2, 2014
07:41 EDTZGNXZogenix updates development of abuse deterrent formulations of Zohydro ER
Zogenix announced an update on its development programs focused on the introduction of abuse deterrent formulations of Zohydro ER Extended-Release Capsules, CII. Zohydro ER is indicated 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. The company has previously indicated that it is simultaneously developing two distinct approaches for abuse deterrent formulations of Zohydro ER. Following a recent meeting with the FDA, Zogenix expects to file a supplemental new drug application, or sNDA, by October for a next-generation formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration. If approved, this new formulation could be available to prescribers in early 2015. The company will continue to characterize the product's abuse deterrent properties with the goal of further amending the labeling for Zohydro ER Extended-Release Capsules in 2015 to include abuse deterrence claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids Evaluation and Labeling.
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October 5, 2015
16:28 EDTZGNXGreat Point raises passive stake in Zogenix to 5.93%
September 30, 2015
08:07 EDTZGNXZogenix reports positive top-line results from Relday Phase 1b clinical trial
Zogenix announced positive top-line pharmacokinetic results from its Phase 1b multi-dose clinical trial of Relday, a proprietary, once-monthly subcutaneous investigational formulation of risperidone for the treatment of schizophrenia. If approved, Relday has the potential to be the first subcutaneous antipsychotic product that achieves therapeutic drug levels on the first day of administration, allows for once-monthly dosing and does not require reconstitution. Zogenix has retained Locust Walk Partners of Cambridge, MA, a transaction advisory firm for life sciences companies, to provide transaction advisory and support services for Relday, and has now initiated efforts to secure a global strategic development and commercialization partner for Relday. The Phase 1b multi-dose parallel group clinical trial enrolled 60 subjects comprised of three cohorts of patients receiving four monthly injections of Relday, at dose levels of either 60, 90 or 120 mg of risperidone per month. A fourth cohort received five bi-weekly intramuscular injections of Risperdal Consta. Risperdal Consta requires oral supplementation for the first three weeks following dosing initiation, and requires at least four doses to reach steady state. The results for Relday demonstrated that risperidone plasma concentrations in the therapeutic range were achieved on the first day of dosing, reached steady state levels following the second dose and consistently maintained therapeutic levels throughout the four-month period. In addition, dose proportionality was confirmed across the dose range intended for clinical practice (60 to 120 mg). Relday was generally safe and well-tolerated, with results consistent with the profile of risperidone and the Company's previous Phase 1 single-dose clinical trial.

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