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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.
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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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