logo
  Join        Login             Stock Quote

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.

iOnTheMarket Premium
Advertisement

Advertisement


Post Comment -- Login is required to post message
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
 

rss feed

Latest Stories

article imageEstee Lauder Companies Inc. (EL) Q4 Earnings Preview: Options Player Betting On EL’s EPS Looking Pretty

Estee Lauder Companies Inc. (NYSE:EL) will release fiscal 2014 fourth quarter and full year financial read on...

article imageHerbalife Ltd. (HLF): 3 Reasons To Pay Attention to Recent Insider Buying

Well, well, well… it looks as if boardroom buyers viewed the recent selloff as an opportunity to buy. read on...

article imageApplied Materials, Inc. (AMAT) Q3 Earnings Preview: Marginally Better than Expected

Applied Materials, Inc.(NASDAQ:AMAT) will hold a webcast to discuss its third quarter of fiscal 2014 read on...

article imagePlug Power Inc. (PLUG) Q2 Earnings Preview: Guidance to Power PLUG’s Direction

Plug Power Inc. (NASDAQ:PLUG) will release the Company's 2014 second quarter results on August 14, 2014. read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.