SAN DIEGO, Feb. 12, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today announced the formation of an External Safe-Use Board. The Board will be a key part of the company's comprehensive approach supporting the appropriate use of Zohydro TM ER (hydrocodone bitartrate) extended-release capsules, the first and only extended-release hydrocodone without acetaminophen 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. The areas of expertise of the standing members of the Board are matched to ensure Zogenix will receive timely, independent and thorough feedback and recommendations regarding the use of Zohydro ER after launch in early March. The Board will meet regularly to review a variety of data inputs regarding the medication's prescribing and use.
"Instituting the External Safe-Use Board is another example of our commitment to responsible commercialization of our products," said Roger Hawley, chief executive officer of Zogenix. "The important role of this Board serves to report independent assessments, interpretations and recommendations regarding the use of Zohydro ER directly to the Board of Directors of Zogenix and to me. Our intentions are to proactively share this information with the Food & Drug Administration (FDA). This will be the first time that a Schedule II opioid product will have launched with an expert, independent safety review board in place from the first day of product availability."
Chairperson of the External Safe-Use Board, Jeffrey Gudin, MD, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey, said, "This type of voluntary initiative on the part of Zogenix, will allow external, highly experienced specialists, to provide valuable insight and advice about the impact of introducing this new pain treatment to the community and, if needed, to recommend specific actions needed to ensure that the risk of abuse, misuse and diversion is minimized. The creation of this Board exemplifies Zogenix's commitment to the appropriate use of Zohydro ER."