Zogenix Provides Update on Zohydro(TM) ER Regulatory Review
"We are confident in the Zohydro ER program and our NDA submission and are committed to working with the
If approved, Zohydro ER will be classified as a
About Zohydro ER
Zohydro ER is an 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 hydrocodone therapy without acetaminophen for the management of chronic 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 100 million people in
Chronic pain can be managed with both immediate-release and extended-release opioids. Currently marketed hydrocodone products are only immediate-release and contain an analgesic combination ingredient, primarily acetaminophen. Acetaminophen may cause liver injury when used in high dosages, over long periods of time or in accidental overdoses due to multiple acetaminophen products being taken at once.
SUMAVEL®, DosePro®, ReldayTM and ZohydroTM ER are trademarks of
SODAS® is a trademark of
Zack Kubow| The Ruth Group646.536.7020 | firstname.lastname@example.org Media Emily Poe| WCG 212.301.7183 | email@example.com