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Posted 30 Jan 2015 by Drugs.com
SAN DIEGO, Jan. 30, 2015 – Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™. BeadTek is a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended. Concurrently, Zogenix has ongoing Human Abuse Liability studies, which will further characterize the abuse-deterrent properties of the new formulation. Zogenix intends to submit these data in the second half of 2015 to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDA's current draft Guidance for Industry, ... Read more