Eighteen months after the Food and Drug Administration (FDA) approved Zogenix Inc.’s powerful opioid painkiller Zyhydro despite abuse concerns from consumer groups and lawmakers, the agency has finalized its guidance urging drug makers to devise abuse-deterrent versions of opioids as they move forward.
The new formulations of opioids – some of which have already hit the market – are manufactured in a way that prevents them from being crushed and injected or snorted, which many of these painkillers are for a stronger, more intense high, contributing to the country’s prescription drug abuse epidemic.
The FDA guidance informs drug makers of the types of clinical trials that should be conducted in order to determine the abuse resistance of a drug. However, the guidance is not binding to manufacturers.
The agency also said it is still working on similar guidelines for manufacturers of generic opioids. Much of the hesitance on the FDA’s part is ensuring that crucial patients, such as those on hospice, can still have access to crushable versions of the drugs.
In October 2013, the FDA came under fire for its approval of Zohydro, a pure hydrocodone for moderate to severe pain. Opioids, which include oxycodone and morphine, are the most abused drugs in the United States.
The FDA’s approval of Zyhydro raised red flags with consumer groups. A group of attorneys general petitioned the agency to rethink its decision to approve Zohydro but the agency refused, saying there was a need for a pure hydrocodone on the market. Since then, Zogenix has released an abuse-resistant version of the drug.
Source: Law 360