Zogenix Submits Modified Formulation Of Zohydro ER For FDA Review - Quick Facts

(RTTNews) - Zogenix Inc. (ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system or CNS disorders, said that it has submitted to the U.S. Food and Drug Administration or FDA a supplemental New Drug Application or sNDA for a modified formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, which has been designed to have abuse deterrent properties.

The company noted that 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.

Zohydro ER is an extended-release opioid agonist 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.