On Friday, the plan of introduction of pure hydrocodone painkiller was strongly condemned by the FDA panel. The US Food and Drug Administration questioned in return to the proposal why there is a need to introduce a new form of the drug, which is already highly abused.
The report finds that the drug is amongst those painkillers that are generally highly taken by people. San Diego-based Zogenix Inc. had developed the drug for relieving long-acting pain. The same has received 11-2 vote by the team of pain specialists.
Amongst the votes, one was a no vote against Zohydro, which is for mild to severe chronic pain. However, the FDA usually does not deny to the group's recommendation, it is this time that the regulator has rejected the proposed plan.
The panelists are acknowledging that the pill has the potential to cut pain, but the drug abuse issue in the nation may expand. The FDA would now make a decision over the drug by March 1, as per the findings.
Harvard School of Public Health's Professor James Ware said, "I think the sponsor fulfilled the expectations of FDA, however I think the entire class is problematic in terms of abuse and safety issues".