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Zogenix (ZGNX): FDA Advisory Committee to Review Chronic Pain Treatment Candidate

 November 08, 2012 10:37 AM

(By Balachander) Zogenix Inc. (NASDAQ: ZGNX) said an advisory committee of the U.S. Food and Drug Administration (FDA) will review its new drug application (NDA) for Zohydro ER on December 7, 2012.

Shares surged 9.33 percent to trade at $2.46 early Thursday.

The pharmaceutical company is developing products for the treatment of central nervous system disorders and pain.

Zohydro ER is Zogenix's lead investigational product candidate for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

"If approved, Zohydro ER could be the first extended-release novel formulation (without acetaminophen) hydrocodone therapy for pain, avoiding the potential for liver injury associated with the use of acetaminophen in high doses or over long periods of time," Zogenix said.

[Related -Zogenix: Zohydro Approval Unlikely Following Negative Panel]

The Prescription Drug User Fee Act (PDUFA) date for completion of the review by the FDA is March 1, 2013.

According to Zogenix, an estimated 116 million people in the United States are burdened with chronic pain, at an estimated national economic cost of $560 billion to $635 billion annually.

Zogenix's first commercial product, SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache.

The company's second DosePro investigational product candidate, Relday, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.

[Related -Zogenix (ZGNX) Starts Relday Clinical Trial For Schizophrenia]

In May 2012, Zogenix submitted a NDA to the FDA for Zohydro ER and an Investigational New Drug Application for Relday. 

The stock, which has been trading in a 52-week range of $1.31 to $3.30, traded 20 cents higher at $2.45 on Thursday.



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