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1-Nov-13 9:00 AM  CST  

FDA Approves Single-entity Hydrocodone Drug Zohydro ER 

The Food and Drug Administration (FDA) has approved Zohydro ER (hydrocodone bitartrate extended-release capsules) to treat severe pain.  The drug is designed to help individuals with severe 24 hour pain in which alternative drug options have failed.    

           Zohydro ER is manufactured by Zogenix, Inc, and is the first FDA approved hydrocodone product that is not combined with an analgesic which makes it unique to patients and physicians looking for alternative medications to treat pain.  It should be noted that this new drug should not be used as an as needed drug.     

            New labeling and updated warnings about the potential for drug abuse with such hydrocodone drugs will hopefully help cut down on social problems such as drug abuse, addiction, and doctor shopping.  According to a recent FDA press release, the most common side-effects associated with Zohydro ER are nausea, constipation, somnolence, fatigue, dizziness, headache, dry mouth, vomiting, and itching. 

            "Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids. It is the first extended-release hydrocodone medicine that is acetaminophen-free. Also, a significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients," said Dr. Srinivas Nalamachu, M.D., Pain Specialist at the International Clinical Research Institute, Overland Park, Kansas and investigator in the clinical trials of Zohydro ER.       

            Pharmacy technicians can learn more about Zohydro ER by going to




1.  Normart, Julie.  “Zogenix Receives FDA Approval for Zohydro ER.”  Zogenix Inc.  Web.  Date of Access:  28 Oct 2013. 


2.  Liscinsky, Morgan.  “FDA Approves Extended-release, single-entity hydrocodone Product.”  Web.  Date of Access:  28 Oct 2013. 



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Jennifer O' Reilly

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