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News Breaks
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analgesic with FDA-approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry, the FDA stated.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.
News For ZGNX From The Last 14 Days
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November 20, 2014
14:26 EDTZGNXZogenix slips after FDA approves new extended-release opioid analgesic
Shares of Zogenix, the maker of Zohydro ER, are lower in afternoon trading after the FDA approved Hysingla ER, another extended-release opioid analgesic. WHAT'S NEW: Earlier, the Food and Drug Administration announced it has approved Hysingla ER, which is an extended-release 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. Hysingla ER has approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry. Hysingla ER is manufactured by Purdue Pharma. WHAT'S NOTABLE: Janet Woodcock, the director of the Center for Drug Evaluation and Research, stated in a post to the "FDA Voice" blog, that the approval of Hysingla ER marks additional progress in the fight against the ongoing misuse and abuse of prescription opioids. In her blog post, Woodcock stated: "While Hysingla ER has the same active ingredient, hydrocodone, as Zohydro ER, the only other approved extended-release hydrocodone product, there are important differences between the two." Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not, Woodcock noted. The CDER director also stated that the FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER. PRICE ACTION: In afternoon trading, shares of Zogenix slipped 1.7% to $1.18.

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