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March 21, 2014
12:43 EDTZGNXZogenix calls news reports on Zohydro 'false and misleading'
Zogenix disclosed that on March 20 it issued a letter from its CEO to stakeholders addressing certain statements that have been made about the company and its product, Zohydro ER extended-release capsules. The letter stated in part, "An increasing number of news reports have been including false and misleading statements about our company and our product, Zohydro ER extended-release capsules, the first and only extended release hydrocodone product without acetaminophen. This misinformation has created negative perceptions about Zohydro ER, which was approved by the FDA in October 2013 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...In reality, any drug that is not used as prescribed presents a danger to the person abusing the medicine...We further would like to note that without justification, inaccurate allegations have been made that Zogenix paid a university to arrange meetings with the FDA to secure approval of Zohydro ER...On behalf of severe chronic pain sufferers who will potentially benefit from Zohydro ER, we will continue to move aggressively to correct these false and misleading statements. The plight of people living with severe chronic pain should not be politicized. We encourage representatives of the news media who are reporting on Zohydro ER to contact us directly and we will gladly share the facts."
News For ZGNX From The Last 14 Days
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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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