- Zogenix has submitted a supplemental New Drug Application (sNDA) to the FDA for a new formulation of its extended release opioid painkiller, Zohydro ER, that makes the drug more difficult to abuse.
- According to a press release, the new formulation "contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection and nasal insufflation."
- Zogenix's goal is to have the sNDA approved by Q1 2015 and to transition to the new formula by Q2 2015.
Sales of the controversial new painkiller Zohydro have been rising steadily, leading some investors to think that Zogenix has a blockbuster on its hands. But major crackdowns on opioid painkillers (the governor of Massachusetts unsuccessfully attempted to ban sales of Zohydro in the state) in the face of America's prescription painkiller addiction epidemic had some feeling bear-ish on the drug.
Now, Zogenix has responded with a new formulation aimed at easing public health officials' fears of having yet another addictive painkiller on the market.
Recently, the FDA rejected requests to establish a new rule that would have forced drug makers who make CNS-acting painkillers to change their formulations to make them harder to abuse.