Zogenix Establishes External Safe-Use Board
Experts to Provide Independent Oversight and Recommendations
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."
The members of the External Safe-Use Board consist of widely recognized
experts in pain management, risk management, pharmacovigilance, surveillance,
addiction, patient care and law enforcement. The Board members will meet
quarterly and have responsibility for interpreting and identifying the
assessment of the benefit/risk profile of Zohydro ER, effectiveness of the
current surveillance tools, current education and prevention programs, and
identification of opportunities to enhance signal detection or risk mitigation
Zogenix is committed to promoting the appropriate use of Zohydro ER through a
comprehensive suite of voluntary initiatives, which include integrated
educational resources for patients, prescribers and pharmacists, surveillance
programs to identify misuse, abuse and diversion, commercial activity focused
on selected prescribers experienced with managing pain using Schedule II
extended-release opioids, education and training requirements for Zogenix
territory representatives who will be compensated on achieving educational
goals during launch year and provision of safe storage mechanisms for
In addition, Zogenix is fully engaged in developing an abuse deterrent
formulation of Zohydro ER, as announced in November 2013, consistent with the
Food & Drug Administration's (FDA) draft guidance for the industry on the
evaluation and labeling of abuse deterrent opioids.
External Safe-Use Board
Jeffrey Gudin, MD – Chairperson; Pain Management Specialist
Dr. Gudin is currently Director of Pain Management and Palliative Care at
Englewood Hospital and Medical Center in New Jersey, an affiliate of the Mount
Sinai School of Medicine. His clinical and research focus includes the safe
use of controlled substances for the treatment of pain, preemptive analgesia,
and increasing clinician awareness of pain management and palliative
care.Heis board certified in Pain Medicine, Anesthesiology, Addiction
Medicine and Hospice and Palliative Care.
John J. Burke – Law Enforcement Specialist
Commander Burke has been a law enforcement officer for over 43 years. He is
the president of the non-profit organization, National Association of Drug
Diversion Investigators, and is the owner and president of Pharmaceutical
Diversion Education Inc., a company which provides education and consulting
work on a wide variety of prescription drug abuse issues to law enforcement,
health professionals, and the pharmaceutical industry.
Debra Gordon, RN, DNP, FAAN – Patient Advocate
Dr. Gordon is a Teaching Associate with the Department of Anesthesiology &
Pain Medicine at the University of Washington (UW), Seattle. She works in
conjunction with the inpatient and outpatient Pain Relief Services, clinics
and hospital staff to collaborate on improving systems of care and designing
outcome evaluations that benefit patients and populations across the continuum
of care. She has also been involved in a number of national and international
projects focused on improving the quality and safety of pain management.
Herbert Neuman, MD, MBA – Pharmacovigilance Expert
Dr. Neuman, President of R3xperts LLC, has Dr. Neuman, President of R3xperts
LLC, has designed global drug safety and risk management systems for multiple
companies and advises healthcare firms on a broad range of product safety
issues. He has experience working with the FDA to understand and mitigate
important drug safety and risk management issues.
Scott Novak, PhD – Surveillance Expert
Dr. Novak, Senior Developmental Epidemiologist at RTI International, holds
research interests in the causes, correlates, and consequences of substance
use, including the behavioral and psychiatric sequelae. He currently directs
the program of research on prescription drug abuse within RTI's behavioral
health epidemiology program. He is also active in studies investigating the
epidemiology of new synthetic/designer drugs of abuse in the United States and
Steven Passik, PhD – Addiction Specialist
Dr. Passik is the Director of Clinical Addiction Research and Education at
Millennium Laboratories and is a Professor of Psychiatry and Anesthesiology at
Vanderbilt University Medical Center in Nashville, Tennessee. He has served on
the editorial board of several peer-reviewed pain management journals, and was
the president of the Indiana Cancer and AIDS Pain Initiative and the editor in
chief of the National Cancer Institute's PDQ Supportive Care Editorial Board.
Joseph Pergolizzi, Jr., MD – Risk Management Expert
Dr. Pergolizzi is a senior partner in the Naples Anesthesia and Physician
Associates Group and Chairman of the Board of the Association of Chronic Pain
Patients. He has served as a member of various medical and scientific
societies and acted on a number of institutional committees including the
Medical Errors Committee and Pharmacy and Therapeutics Committee, and is also
a participant of the FDA's Safe Use Initiative Roundtable.
About Zohydro ER
Zohydro™ ER is an opioid agonist, extended-release, oral formulation of
hydrocodone bitartrate 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.
LIMITATIONS OF USE
Because of the risks of addiction, abuse, and misuse with opioids, even at
recommended doses, and because of the greater risks of overdose and death with
extended-release opioid formulations, reserve Zohydro ER for use in patients
for whom alternative treatment options (e.g., non-opioid analgesics or
immediate-release opioids) are ineffective, not tolerated, or would be
otherwise inadequate to provide sufficient management of pain.
Zohydro ER is not indicated for use as an as‑needed (prn) analgesic.
Please see the Zohydro ER full prescribing information for the complete boxed
warning and safety information.
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION;
ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME and INTERACTION WITH
*Zohydro ER exposes users to risks of addiction, abuse, and misuse, which
can lead to overdose and death.Assess each patient's risk before
prescribing, and monitor regularly for development of these behaviors or
*Serious, life-threatening, or fatal respiratory depression may
occur.Monitor closely, especially upon initiation or following a dose
increase.Instruct patients to swallow Zohydro ER whole to avoid exposure
to a potentially fatal dose of hydrocodone.
*Accidental consumption of Zohydro ER, especially in children, can result
in fatal overdose of hydrocodone.
*For patients who require opioid therapy while pregnant, be aware that
infants may require treatment for neonatal opioid withdrawal
syndrome.Prolonged use during pregnancy can result in life-threatening
neonatal opioid withdrawal syndrome.
*Instruct patients not to consume alcohol or any products containing
alcohol while taking ZohydroER because co-ingestion can result in fatal
plasma hydrocodone levels.
IMPORTANT SAFETY INFORMATION
Zohydro ER is contraindicated in patients with: significant respiratory
depression; acute or severe bronchial asthma or hypercarbia; known or
suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate or
any other ingredients in Zohydro ER.
Zohydro ER contains hydrocodone, a Schedule II controlled substance.As an
opioid, Zohydro ER exposes users to the risks of addiction, abuse, and
misuse.As modified-release products, such as Zohydro ER, deliver the opioid
over an extended period of time, there is a greater risk for overdose and
death due to the larger amount of hydrocodone present.
Potential serious adverse events caused by opioids include respiratory
depression, potential for misuse and abuse, CNS depressant effects, prolonged
gastric obstruction, and severe hypotension. The most common adverse reactions
associated with Zohydro ER ( ≥ 2%) include constipation, nausea, somnolence,
fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain,
peripheral edema, upper respiratory tract infection, muscle spasms, urinary
tract infection, back pain and tremor.
For more information about Zohydro ER, please visit:www.ZohydroEr.com or the
Zohydro ER REMS website at www.ZohydroERREMS.com.
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville,
California, is a pharmaceutical company committed to developing and
commercializing therapies that address specific clinical needs for people
living with pain-related conditions and CNS disorders who need innovative
treatment alternatives to help them return to normal daily functioning.
Zogenix developed and commercialized the first needle-free subcutaneous
injection, SUMAVEL® DosePro® (sumatriptan injection), for migraine and cluster
headache. Zogenix received FDA approval for Zohydro ER (hydrocodone
bitartrate) extended-release capsules, the first extended-release oral
formulation of hydrocodone without acetaminophen. The development pipeline for
Zogenix includes a once-monthly subcutaneous injection for schizophrenia.
Zogenix cautions you that statements included in this press release that are
not a description of historical facts are forward-looking statements. Words
such as "believes," "anticipates," "plans," "expects," "indicates," "will,"
"intends," "potential," "suggests," "assuming," "designed" and similar
expressions are intended to identify forward-looking statements. These
statements are based on the company's current beliefs and expectations. These
forward-looking statements include statements regarding: the ability to ensure
that the risk of abuse, misuse and diversion of Zohydro ER is minimized and
the potential to develop an abuse deterrent formulation of Zohydro ER. The
inclusion of forward-looking statements should not be regarded as a
representation by Zogenix that any of its plans will be achieved. Actual
results may differ from those set forth in this press release due to the risk
and uncertainties inherent in Zogenix's business, including, without
limitation: Zogenix's ability to adequately ensure that the risk of abuse,
misuse and diversion of Zohydro ER is minimized; risks and uncertainties
associated with the development and regulatory approval of an abuse deterrent
formulation of Zohydro ER; the timing and success of any subsequent commercial
launch of Zohydro ER; Zogenix's ability to successfully launch and drive
market demand for Zohydro ER; Zogenix's ability to obtain additional financing
as needed to support its operations; the scope and validity of patent
protection for Zohydro ER and Zogenix's ability to commercialize Zohydro ER
without infringing the patent rights of others; unexpected adverse side
effects or inadequate therapeutic efficacy of Zohydro ER that could limit
commercialization, or that could result in recalls or product liability
claims; competition from other pharmaceutical or biotechnology companies;
other difficulties or delays relating to the development, testing,
manufacturing and marketing of and obtaining regulatory approval for an abuse
deterrent formulation of Zohydro ER; and other risks detailed in Zogenix's
prior press releases as well as in public periodic filings with the Securities
and Exchange Commission. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date hereof, and
Zogenix undertakes no obligation to revise or update this press release to
reflect events or circumstances after the date hereof. All forward-looking
statements are qualified in their entirety by this cautionary statement. This
caution is made under the safe harbor provisions of Section 21E of the Private
Securities Litigation Reform Act of 1995.
Zohydro^TM ER is a trademark and SUMAVEL^® and DosePro^® are registered
trademarks of Zogenix, Inc.
Zack Kubow | The Ruth Group
646.536.7020 | email@example.com
Julie Normart | WCG
415.946.1087 | firstname.lastname@example.org
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