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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."
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January 30, 2015
19:44 EDTZGNXZogenix receives FDA approval of new formulation of Zohydro ER
Zogenix announced that the U.S. FDA has approved a new formulation of Zohydro ER Extended-Release Capsules, CII, with BeadTek. BeadTek is a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended. Concurrently, Zogenix has ongoing Human Abuse Liability studies, which will further characterize the abuse-deterrent properties of the new formulation. Zogenix intends to submit these data in the second half of 2015 to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids Evaluation and Labeling. BeadTek incorporates well-known pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents. Zohydro ER is the only long-acting hydrocodone product administered every 12 hours, and the new formulation maintains the same efficacy and pharmacokinetic profile of the original formulation. Transition to Zohydro ER with BeadTek is expected to occur in the second quarter of 2015 for all prescribed strengths ranging from 10 mg to 50 mg, without disruption to patients currently on therapy.
10:00 EDTZGNXFDA PDUFA Date for Zogenix Zohydro ER is January 30, 2015

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