Zogenix Provides Update on Zohydro(TM) ER Regulatory Review

Zogenix Provides Update on Zohydro(TM) ER Regulatory Review

SAN DIEGO, Feb. 26, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a
pharmaceutical company commercializing and developing products for the
treatment of central nervous system disorders and pain, today announced that
it has been informed by the U.S. Food and Drug Administration (FDA) that
Zogenix is unlikely to receive an action letter for its New Drug Application
(NDA) for Zohydro^TM ER (hydrocodone bitartrate extended-release capsules) by
the Prescription Drug User Fee Act (PDUFA) goal date of March 1, 2013. Under
the performance goals set by the FDA under PDUFA, the agency can miss the
prescribed goal date for approximately ten percent of the NDAs that are
submitted each year and still meet the performance goals for review of
priority and standard applications.

The FDA has not provided Zogenix with information as to the reason for the
possible delay, but has indicated that the delay would likely be brief and may
last only several weeks. Zogenix has not been informed of any deficiencies in
the application during the review process to date.

"We are confident in the Zohydro ER program and our NDA submission and are
committed to working with the FDA while it completes its review," said Stephen
Farr, Ph.D., president and chief operating officer of Zogenix. "We believe
there is an important medical need for an extended-release hydrocodone
medicine without acetaminophen and that Zohydro ER can fill this need based on
its safety and efficacy profile. We also understand the public health concerns
regarding the misuse and abuse of all opioids and intend to be a proactive
leader by implementing our proposed efforts to assure safe and appropriate
use."

If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA)
Schedule II drug, making it subject to stricter prescribing and dispensing
rules, compared to the hydrocodone-acetaminophen combination products, which
are classified as Schedule III drugs. The Schedule II designation recognizes
the potential for abuse and dependence, and is an important measure in the
effort to promote appropriate use and minimize the potential of abuse or
diversion of hydrocodone products. Zohydro ER will also have a Risk Evaluation
and Mitigation Strategy (REMS) consistent with the recently introduced
FDA-approved REMS for Extended Release (ER) and Long Acting (LA) Opioids.

About Zohydro ER

Zohydro ER is an oral, novel extended-release formulation of hydrocodone
without acetaminophen for the management of moderate to severe chronic pain in
patients requiring continuous, around-the-clock opioid therapy for an extended
period of time. If approved, Zohydro ER could be the first extended-release
novel formulation hydrocodone therapy without acetaminophen for the management
of chronic pain, avoiding the potential for liver injury associated with the
use of acetaminophen in high doses or over long periods of time.

Zohydro ER uses Alkermes Pharma Ireland Limited's patented Spheroidal Oral
Drug Absorption System (SODAS®) drug delivery technology, which serves to
enhance the release profile of hydrocodone to provide extended-release pain
relief relative to existing immediate-release combination products.

About Chronic Pain

Chronic pain is defined as ongoing or recurrent pain that adversely affects an
individual's well-being. An estimated 100 million people in the United States
are burdened with chronic pain, at an estimated national economic cost of $560
billion to $635 billion annually.

Chronic pain can be managed with both immediate-release and extended-release
opioids. Currently marketed hydrocodone products are only immediate-release
and contain an analgesic combination ingredient, primarily acetaminophen.
Acetaminophen may cause liver injury when used in high dosages, over long
periods of time or in accidental overdoses due to multiple acetaminophen
products being taken at once.

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville,
California, is a pharmaceutical company commercializing and developing
products for the treatment of central nervous system disorders and pain.
Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection)
Needle-free Delivery System, was launched in January 2010 for the acute
treatment of migraine and cluster headache. Zogenix's lead investigational
product candidate, Zohydro™ ER (hydrocodone bitartrate), is an oral,
extended-release formulation of various strengths of hydrocodone, without
acetaminophen, intended for administration every 12 hours for around the clock
management of moderate to severe chronic pain. In May 2012, Zogenix submitted
to the FDA a New Drug Application for Zohydro ER. Zogenix's second
investigational product candidate, Relday™, is a proprietary, long-acting
injectable formulation of risperidone for the treatment of schizophrenia; an
investigational new drug application was submitted to the FDA in May 2012.

Forward-Looking Statements

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 target action
date for the FDA to complete its review of the Zohydro ER NDA; the potential
for Zohydro ER to be the first approved oral extended-release formulation of
hydrocodone without acetaminophen and the timing thereof; and the size of the
chronic pain market and the potential of Zohydro ER to provide a significant
new management alternative and be well positioned in that market. 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: the potential for the FDA to further delay the PDUFA target action
date due to the FDA's internal resource constraints or other reasons; the FDA
following its advisory committee's recommendation to not approve the Zohydro
ER NDA; the uncertainty of the FDA approval process and other regulatory
requirements; the potential for additional safety and abuse deterrence studies
and REMS requirements and the related delay in approval of the Zohydro ER NDA
and/or commercialization of this product candidate; the potential for delays
associated with any additional data required to be submitted by Zogenix in
support of the NDA; the potential for Zohydro ER to receive regulatory
approval on a timely basis or at all; the potential for adverse safety
findings relating to Zohydro ER to delay or prevent regulatory approval or
commercialization; the impact of any inability to raise sufficient capital to
fund ongoing operations; and other risks described in Zogenix's 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.

SUMAVEL^®, DosePro^®, Relday^TM and Zohydro^TM ER are trademarks of Zogenix,
Inc.

SODAS^® is a trademark of Alkermes Pharma Ireland Limited

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