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Zogenix's long-acting painkiller gets FDA approval

Started by riky, October 26, 2013, 09:00:19 AM

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riky

Zogenix's long-acting painkiller gets FDA approval

(Reuters) - Zogenix Inc said the U.S. Food and Drug Administration approved its drug for treating pain severe enough to require around-the-clock, long-term treatment, sending the specialty pharmaceutical company's shares up as much as 54 percent. The drug is approved for use in patients for whom alternate treatment has proved inadequate or ineffective. The FDA requires post-marketing studies for the drug, Zohydro ER, to assess the known risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks. ...

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