This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Zogenix Provides Update On Zohydro(TM) ER Regulatory Review

SAN DIEGO, Feb. 26, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that Zogenix is unlikely to receive an action letter for its New Drug Application (NDA) for Zohydro TM ER (hydrocodone bitartrate extended-release capsules) by the Prescription Drug User Fee Act (PDUFA) goal date of March 1, 2013. Under the performance goals set by the FDA under PDUFA, the agency can miss the prescribed goal date for approximately ten percent of the NDAs that are submitted each year and still meet the performance goals for review of priority and standard applications.

The FDA has not provided Zogenix with information as to the reason for the possible delay, but has indicated that the delay would likely be brief and may last only several weeks. Zogenix has not been informed of any deficiencies in the application during the review process to date.

"We are confident in the Zohydro ER program and our NDA submission and are committed to working with the FDA while it completes its review," said Stephen Farr, Ph.D., president and chief operating officer of Zogenix. "We believe there is an important medical need for an extended-release hydrocodone medicine without acetaminophen and that Zohydro ER can fill this need based on its safety and efficacy profile. We also understand the public health concerns regarding the misuse and abuse of all opioids and intend to be a proactive leader by implementing our proposed efforts to assure safe and appropriate use."

If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, making it subject to stricter prescribing and dispensing rules, compared to the hydrocodone-acetaminophen combination products, which are classified as Schedule III drugs. The Schedule II designation recognizes the potential for abuse and dependence, and is an important measure in the effort to promote appropriate use and minimize the potential of abuse or diversion of hydrocodone products. Zohydro ER will also have a Risk Evaluation and Mitigation Strategy (REMS) consistent with the recently introduced FDA-approved REMS for Extended Release (ER) and Long Acting (LA) Opioids.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,104.29 -27.57 -0.16%
S&P 500 2,014.89 +15.91 0.80%
NASDAQ 4,823.6460 -14.9970 -0.31%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs