Data From Zohydro(TM) ER (hydrocodone bitartrate) Phase 3 Clinical Trial Published in Pain Medicine Demonstrates Its Benefit as

Data From Zohydro(TM) ER (hydrocodone bitartrate) Phase 3 Clinical Trial
Published in Pain Medicine Demonstrates Its Benefit as a Therapeutic Option
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

SAN DIEGO, Feb. 13, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a
pharmaceutical company developing and commercializing products for the
treatment of pain-related conditions and central nervous system disorders,
today announced the publication of results from the Phase 3 clinical study of
Zohydro^TM ER (hydrocodone bitartrate) extended-release capsules, which were
originally reported in 2011 and were used as the basis for the Zohydro ER new
drug application ("NDA"), which was approved by the U.S. Food and Drug
Administration (FDA) in October 2013. The results of Study 801 from the Phase
3 clinical study demonstrate that extended-release hydrocodone was well
tolerated and effective for the treatment of moderate-to-severe chronic low
back pain and was published online in the February issue of the peer-reviewed
journal Pain Medicine. Pain Medicine is the official publication of the
American Academy of Pain Medicine (AAPM).

The study is titled "Single-Entity Hydrocodone Extended-Release Capsules in
Opioid-Tolerant Subjects With Moderate-to-Severe Chronic Low Back Pain: A
Randomized Double-Blind, Placebo-Controlled Study." It is currently available
to subscribers on the journal's website, and will be published in print at a
later date.

"As the first and only extended-release hydrocodone without acetaminophen, we
expect Zohydro ER to fill a critical need for people suffering from chronic
pain who are currently experiencing pain relief with around-the-clock
immediate-release hydrocodone-acetaminophen combination products but are at
risk for liver toxicity. Acetaminophen overdose is a leading cause of acute
liver failure in the United States with almost two-thirds of those cases
related to the use of these products," said Bradley Galer, MD, executive vice
president and chief medical officer of Zogenix. Dr. Galer continued, "In
addition, the comprehensive suite of appropriate use initiatives for Zohydro
ER that Zogenix has initiated, which augment the Risk Evaluation Mitigation
Strategies (REMS) for Extended-Release/Long Acting (ER/LA) Opioids required by
the FDA, is designed to support the proper prescribing and use of our
product."

Overall, Zohydro ER was studied in over 1,100 patients with moderate to severe
chronic pain who participated in Study 801, the pivotal Phase 3 efficacy study
and Study 802, an open-label Phase 3 long-term safety study. The 801 efficacy
study in subjects with chronic low back pain met the primary endpoint in
demonstrating that treatment with Zohydro ER resulted in significantly
improved pain relief compared to placebo. The key secondary endpoints were
also achieved: a significantly higher number of subjects experienced at least
30% improvement in pain intensity from screening to end of study (67.5%,
Zohydro ER versus 31.1%, placebo). The safety profile of Zohydro ER in both
Phase 3 studies was generally well tolerated and the adverse reactions in ≥ 2%
of patients in placebo-controlled trials include constipation, nausea,
somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus,
abdominal pain, edema peripheral, upper respiratory tract infection, muscle
spasms, urinary tract infection, back pain and tremor. Zohydro ER will be
available in six dosage strengths ranging from 10 mg to 50 mg with dosing
every 12 hours.

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 Zohydro ER

INDICATION

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
ALCOHOL

  *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
    conditions.
  *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.

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.

For more information about Zohydro ER, please visit:www.ZohydroEr.com or the
Zohydro ER REMS website at www.ZohydroERREMS.com.

About Zogenix

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 central nervous system disorders who
need innovative treatment alternatives to help them return to normal daily
functioning. The Company has commercialized two products using technology to
enhance the patient experience and has a development pipeline that includes a
once-monthly subcutaneous injection for schizophrenia. More information about
Zogenix is available at www.zogenix.com

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 timing of the
launch of Zohydro ER, the potential of Zohydro ER to compete with
immediate-release hydrocodone-acetaminophencombination products, and the
adequacy of the appropriate use initiatives for Zohydro . 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 timing and
success of the commercial launch of Zohydro ER; competition from other
pharmaceutical or biotechnology companies; 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; other difficulties or delays relating to the
development, testing, manufacturing and marketing of and obtaining regulatory
approval for Zogenix's products; 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.

SODAS^® is a trademark of Alkermes Pharma Ireland Limited

                                     FPR

CONTACT: Investors
         Zack Kubow | The Ruth Group
         646.536.7020 | zkubow@theruthgroup.com
        
         Media
         Julie Normart | WCG
         415.946.1087 | jnormart@wcgworld.com
 
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