The FDA has accepted the review of Zogenix new drug application (NDA) for Zohydro ER (hydrocodone bitartrate extended-release capsules) for the treatment of moderate to severe chronic pain.
Zohydro ER is an oral, single-entity (without acetaminophen) novel extended-release formulation of various strengths of hydrocodone proposed for administration every 12 hours.
Zogenix president and chief operating officer Stephen Farr said if approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products.
"The approval of Zohydro ER would allow appropriate DEA registered physicians to treat chronic pain patients using hydrocodone for moderate to severe pain while avoiding acetaminophen-related liver injury," Farr added.
The company has submitted NDA based on data from more than 1,100 patients with chronic pain participating in the pivotal Phase 3 efficacy study (Study 801) and an open-label Phase 3 safety study (Study 802) of Zohydro ER.