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Stock Market & Financial Investment News

News Breaks
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."
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 Hysingla ER has approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry.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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