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April 23, 2014
07:42 EDTZGNXZogenix responds to Massachussets governor's restriction on Zohydro
Zogenix issued a statement regarding Massachussetts governor Patrick's immediate restriction on Zohydro. The company stated, "Zogenix will continue to work to ensure patients suffering from severe chronic pain have access to the FDA-approved medications they need in every state nationwide, including Massachusetts. (...) Zogenix is following a rigorous program required by the FDA to ensure that Zohydro is used safely and responsibly. Zogenix strongly disagrees with the Governor's decision once again to single out Zohydro ER, when the facts show that the risks of abuse with Zohydro ER are no different than those of most other long-acting opioid products on the market today. (...) Zogenix urges the Governor to respect the carefully designed approach imposed by the FDA, and to address the problem of opioid abuse on a class-wide basis."
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July 25, 2014
08:01 EDTZGNXZogenix price target lowered to $3.50 from $5 at Stifel
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July 23, 2014
16:56 EDTZGNXZogenix competitor gets FDA approval for abuse-deterrent ER oxycodone
The FDA approved Targiniq ER, an extended-release/long-acting opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry, the FDA stated. The FDA is requiring postmarketing studies of Targiniq ER, to assess the serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose, and death associated with long term use beyond 12 weeks. The FDA is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER. In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy. Targiniq ER is manufactured by Purdue Pharma. Zogenix has a competing pain killer drug called Zohydro ER.

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