Zogenix Announces FDA Advisory Committee Review of Zohydro(TM) ER for the Management of Chronic Pain
The Prescription Drug User Fee Act (PDUFA) date for completion of the review by the
The AADPAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human anesthetic and analgesic drug products and makes appropriate recommendations to the Commissioner of Food and Drugs. The AADPAC provides
About Zohydro™ ER
Zohydro ER is an investigational oral, novel extended-release formulation of hydrocodone without acetaminophen for the management of moderate to severe chronic pain in patients requiring continuous, around the clock opioid therapy 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.
Zohydro ER uses
About Chronic Pain
Chronic pain is defined as ongoing or recurrent pain that adversely affects an individual's well-being. An estimated 116 million people in
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Forward Looking Statements
SODAS® is a registered trademark of
SUMAVEL ®, DosePro ®, Relday™ and Zohydro™ ER are trademarks of
Zack Kubow| The Ruth Group646.536.7020 | firstname.lastname@example.org MEDIA: Emily Poe| WCG 212.301.7183 | email@example.com