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March 28, 2014
05:32 EDTZGNXZogenix issues statement on Massachusetts Zohydro ban
Zogenix issued the following statement regarding Massachusetts ban on Zohydro: We agree with Governor Deval Patrick's intention to curb the epidemic of drug abuse in Massachusetts. However, we are extremely concerned by his unprecedented action with respect to a specific FDA-approved prescription medication. We believe Governor Patrick's ban on Zohydro ER only serves to unfairly restrict patient access to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen. Ultimately, the ban on the prescription medication will add to patient suffering in the state. Contrary to some recent media reports, most other opioid medications on the market are both equal to or more potent than Zohydro ER, and all are available in higher strengths per unit-of-use than Zohydro ER. Claims that Zohydro ER is "more powerful" or "more addictive" than other commonly prescribed opioids are not supported by scientific data. Over the last 12 months, more than 360,000 prescriptions for extended-release opioids were dispensed in Massachusetts, and a significant majority did not have FDA-approved abuse deterrent claims. We fail to see how banning the sale of a single new product will achieve the governor's policy objectives when all of the products that are currently part of the epidemic remain available for sale in the state. We are disappointed that today legitimate severe chronic pain patients in Massachusetts received a serious blow in their efforts to find relief for the suffering that affects their, and their families', daily lives. We look forward to engaging with the governor and his representatives to review the safe use measures already in place.
News For ZGNX From The Last 14 Days
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October 8, 2015
16:22 EDTZGNXRA Capital Management reports 7.5% passive stake in Zogenix
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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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