Zohydro ER Faces FDA Rejection
The Food and Drug Administration (FDA) is now opposing the Zohydro ER made by Zogenix Inc. which is stronger and new version of hydrocodone.
The drug was voted very low i. e. 11-2 with one nonparticipation. FDA received the suggestion of government pain expert panel over their rejection since the painkiller was reported to cause high levels of abuse.
Zogenix Inc. is based San Diego who developed the Zohyro ER capsules to cure average to chronic pains. The rejection has emerged as a vital setback for the drug maker since the trades of the drug have been stopped in wake of the news.
However, the FDA will make a final decision about the drug in March 2013 when it will tell whether the drug is safe for use. And if the drug gets the nod from the health officials, US will get its first pure hydrocodone painkiller while those in market as of now are of lower strength.
"There is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER", said Stephen Farr, the President and Chief Operating Officer of Zogenix.
The drugs with hyrocodone and other combinations come under Schedule III drugs while Zohydro ER shall be classified as schedule II drug as it is more powerful.