An expert panel with the US Food and Drug Administration has recommended the health agency not to approve Zogenix Inc's Zohydro painkiller drug as there is a high risk of addiction among the users.
The panel voted 11-2 in favor of the recommendation and said that while the San Diego-based pharmaceutical company did manage to meet the narrow targets for safety and efficacy, there is a risk that people who are addicted to other opioid painkillers may also become addicted to Zohydro, generically known as hydrocodone bitartrate.
AdvertisementHowever the director of FDA's division of anesthesia, Dr Bob Rappaport said that the agency should now decide on whether the panel's recommendation was based on tangible evidence. "Otherwise you're punishing this company and this drug because of the sins of the previous developers and their products. And from a regulatory standpoint, that's not really something we can do", he said.