Zogenix Reports Positive Results From Relday(TM) Phase 1 Clinical Trial

Zogenix Reports Positive Results From Relday(TM) Phase 1 Clinical Trial

Plans to Seek Partner and Accelerate Development of Once-Monthly Subcutaneous
Formulation of Risperidone for Schizophrenia

SAN DIEGO, Jan. 3, 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
positive single-dose pharmacokinetic (PK) results from the Phase 1 clinical
trial of Relday™, an investigational candidate of a proprietary, once-monthly
subcutaneous formulation of risperidone for the treatment of schizophrenia.
Adverse events in the Phase 1 trial in patients diagnosed with schizophrenia
were generally mild to moderate and consistent with other risperidone
products.

Based on the favorable safety and PK profile demonstrated with the 25 mg and
50 mg once-monthly doses tested in the Phase 1 trial, Zogenix has extended the
current study to include a 100 mg dose of the same formulation. The addition
of this dose arm to the study will enable evaluation of dose proportionality
across the full dose range that would be anticipated to be used in clinical
practice. Positive results from this study extension would better position
Zogenix to begin a multi-dose clinical trial, which would provide the required
steady-state PK and safety data prior to initiating Phase 3 development
studies. Zogenix expects to complete the extension of the Phase 1 clinical
trial during the second quarter of 2013.

Roger L. Hawley, chief executive officer of Zogenix, said, "The positive
results from the first Relday study provide proof-of-concept for a novel,
long-acting, subcutaneous formulation of an established antipsychotic to
provide psychiatrists and their patients with an improved treatment option.
Because the PK profile, overall safety results and injection site reactions
were all favorable, we can now begin discussions with potential partners for
rest-of-world development and commercialization as we continue with the 100 mg
single-dose study extension of Relday. We believe the data from all three
dosage strengths will allow us to accelerate both the 505(b)(2) development
timeline and the potential identification of an appropriate partner prior to
starting the multi-dose clinical trial."

Because this approach involves selecting the dose by administering different
volumes of the same formulation by a healthcare professional, the development
of Relday will first focus on delivery by conventional needle and syringe
while accelerating the overall program timeline. The introduction of the
DosePro needle-free technology can occur later in development or as part of
life cycle management after further work involving formulation development,
technology enhancements, and applicable regulatory approvals.

Risperidone is one of the most widely prescribed medications used to treat the
symptoms of schizophrenia in adults and teenagers 13 years of age and older.
The global long-acting injectable antipsychotic market was approximately $2
billion in 2011. The leading injectable product in the category requires
twice-a-month dosing, intramuscular injection and drug reconstitution prior to
use. The combined market for oral and injectable antipsychotic products was
estimated at more than $17 billion in 2011.

About Relday^TM

If approved, Relday will be the first subcutaneous antipsychotic product that
allows for once-monthly dosing. Zogenix believes that Relday will offer an
improved PK profile, significant reduction in injection volume and a
simplified dosing regimen due to DURECT's (NASDAQ: DRRX) SABER^®
controlled-release depot technology. In July 2011, Zogenix licensed from
DURECT exclusive global rights to develop and commercialize this proprietary
formulation which utilizes DURECT's SABER^® depot technology.

The Phase 1 clinical trial for Relday was conducted as a single-center,
open-label, safety and PK trial of 30 patients with chronic, stable
schizophrenia or schizoaffective disorder. The study will be extended to
include an additional cohort of 10 patients at a 100 mg dose.

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 and was assigned a
PDUFA target action date of March 1, 2013 by the FDA. 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.

For additional information, please visit 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" 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 delivery and dosing benefits of Relday
to both the patient and clinician, initiation of a multi-dose clinical trial
and Phase 3 development studies for Relday, timing of completion of the
extension of the Phase 1 trial, discussions with potential partners for
rest-of-world development and commercialization of Relday, Zogenix's steps to
accelerate both the 505(b)(2) development timeline and the potential
identification of an appropriate partner for Relday, the introduction of
DosePro technology and the timing thereof, the ability of such product to
address the global anti-psychotic market, and the ability to develop a
once-monthly injectable product with improved pharmacokinetics and significant
reduction in injection volume,. 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
release due to the risk and uncertainties inherent in Zogenix's business,
including, without limitation: the uncertainties associated with the clinical
development and regulatory approval of product candidates such as Relday,
including potential delays in enrollment and completion of clinical trials;
Zogenix's dependence on its collaboration with DURECT Corporation to develop
Relday; inadequate therapeutic efficacy or unexpected adverse side effects
relating to Relday that could prevent its development or commercialization;
difficulties in identifying, negotiating, executing and carrying out strategic
transactions relating to Relday; the market potential for anti-psychotics, and
Zogenix's ability to compete within that market; ability to obtain and the
validity and duration of patent protection and other intellectual property
rights for Relday; and other risks described in the company's prior press
releases and 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 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.

SABER^® is a trademark of DURECT Corporation.

CONTACT: Investor Contact
         Zack Kubow | The Ruth Group
         646.536.7020 | zkubow@theruthgroup.com
        
         Media Contact
         Caitlin Cox | The Ruth Group
         646.536.7033 | ccox@theruthgroup.com