Abuse deterrent formulation of Zohydro filed at FDA for severe pain control - Zogenix

Zogenix, Inc. has announced it has submitted to the FDA a supplemental New Drug Application (sNDA) for a modified formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, which has been designed to have abuse deterrent properties. The new capsule formulation contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection and nasal insufflation. The Company anticipates a target action date on the supplement during the first quarter of 2015, and, if approved, a transition from the currently marketed product to this new formulation of Zohydro ER in the second quarter of 2015.

Zohydro ER is indicated for the management of pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.