SAN DIEGO, Oct. 1, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, announced that it has been informed today by the U.S. Food and Drug Administration (FDA) that an action letter on the New Drug Application (NDA) for Zohydro TM ER (hydrocodone bitartrate) extended-release capsules could follow after a further delay of short duration. The FDA had previously informed the company that it expected to issue an action letter over the summer. The original PDUFA goal date was March 1, 2013.
On September 10, 2013, the FDA announced safety labeling changes and post-marketing requirements for extended-release (ER) and long-acting (LA) opioid analgesics. Previously, the FDA had indicated a decision on the Zohydro ER NDA could follow after a significant class-wide action on ER/LA opioid analgesics. Following the announcement, Zogenix and the FDA have completed the final labeling and reached agreement on the post-marketing requirements for Zohydro ER. The FDA has also reconfirmed there are no deficiencies in the NDA. While the FDA indicated its intent to take prompt action on the Zohydro ER NDA, the timing for a decision may be impacted by the current government shutdown. The FDA indicated earlier today that agency activities funded by PDUFA user-fees remain operational.
If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, making it subject to strict prescribing and dispensing rules, compared to the hydrocodone-acetaminophen combination products, which are classified as Schedule III controlled substances. The Schedule II designation 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 FDA approved REMS for ER/LA opioids.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV