New Zohydro ER Formulation sNDA Submitted to FDA
Zogenix announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for a modified formulation of Zohydro ER (hydrocodone bitartrate) extended-release capsules.
The new formulation contains more inactive ingredients intended to make the drug more difficult to abuse by injection and nasal insufflation.
Zohydro ER was approved in October 2013 for the management of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment (eg, non-opioid analgesic or immediate-release opioids) are inadequate.
Zogenix anticipates the launch of Zohdryo ER's new formulation in the second quarter of 2015.
For more information call (866) 964-3649 or visit ZohydroER.com.