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March 12, 2014
11:36 EDTZGNXZogenix plummets after rival advances abuse-resistant painkiller
Shares of Zogenix (ZGNX), which develops drugs for pain-related conditions, are lower after rival Purdue Pharma unveiled data on a study of its own abuse resistant painkiller. WHAT'S NEW: Earlier today, Purdue Pharma announced that a Phase 3 study of an investigational extended-release formulation of hydrocodone bitartrate met its primary efficacy endpoint. The company added that this investigational single-entity opioid analgesic formulation incorporates abuse-deterrent properties intended to make the tablets more difficult to manipulate for the purpose of misuse and abuse. Purdue Pharma's Senior Vice President of Research and Development Gary Stiles said, "We are very encouraged by the results of this pivotal study. This is another step forward in our efforts to develop therapeutic options for use by chronic pain patients that are designed to be unattractive to drug seekers." Purdue said it plans to file a New Drug Application with the FDA later in 2014 requesting approval to market the medication. Zogenix recently released Zohydro, a powerful opioid painkiller, that has been highly criticized for its abuse potential. PRICE ACTION: Shares of Zogenix are down almost 18% to $3.73 in morning trading. Shares of Zogenix had doubled since getting FDA approval for Zohydro in late October. Purdue Pharma is a private company.
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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analgesic with FDA-approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry, the FDA stated.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.
July 14, 2014
08:36 EDTZGNXZogenix announces patent for DosePro Needle-free Delivery System
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