DURECT Announces Positive Results from Relday™ Phase 1 Clinical Trial

    DURECT Announces Positive Results from Relday™ Phase 1 Clinical Trial

PR Newswire

CUPERTINO, Calif., Jan. 3, 2013

CUPERTINO, Calif., Jan. 3, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq:
DRRX) announced that its licensee, Zogenix Inc. (Nasdaq: ZGNX), today reported
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.
According to Zogenix, adverse events in the Phase 1 trial in patients
diagnosed with schizophrenia were generally mild to moderate and consistent
with other risperidone products.

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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. Per Zogenix, 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 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.
Zogenix expects to complete the extension of the Phase 1 clinical trial
during the second quarter of 2013.

James E. Brown, D.V.M., President and CEO of DURECT, stated, "We're pleased
with these results from the first Relday study and with Zogenix'sextension
ofthe study to a higher dose. We believe this formulation of risperidone,
designed to be dosed once a month through a subcutaneous rather than
intramuscular injection, would provide patient and clinician benefits relative
to existing risperidone products. Relday joins POSIDUR^™
(SABER^®-bupivacaine), for which we anticipate filing an NDA in the first
quarter of 2013, as our second depot injectable therapeutic in clinical
development."

About Relday^™
On July11, 2011, DURECT and Zogenix entered into a development and license
agreement for the purpose of developing and commercializing Relday, a
proprietary, long-acting injectable formulation of risperidone using our
SABER^® depot technology. Risperidone is one of the most widely prescribed
medications used to treat the symptoms of schizophrenia and bipolar I disorder
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 product in the category requires twice-a-month dosing via
intramuscular injections and drug reconstitution prior to use. We believe
that Relday may offer an improved pharmacokinetic profile, reduction in
injection volume and a simplified dosing regimen relative to existing
risperidone products. Under the agreement, we granted Zogenix worldwide
development and commercialization rights to Relday.

About DURECT's Depot Programs
In addition to two products in development using our depot technology (POSIDUR
and Relday), we have multiple feasibility projects underway and one animal
health drug (SucroMate™ Equine) which is approved and being commercialized
through our licensee (CreoSalus, Inc.). DURECT has developed significant
capabilities in the area of depot injectable technology which allows for
proprietary product development with delivery periods of days to months.
Programs utilizing our depot technology also benefit from the custom polymer
expertise residing within our Birmingham, Alabama group where we manufacture
polymeric components under the LACTEL^® brand name for 13 FDA approved
products.

About DURECT Corporation

DURECT is a specialty pharmaceutical company developing innovative drugs for
pain and other chronic diseases, with late-stage development programs
including REMOXY^®, POSIDUR^™, ELADUR^®, and TRANSDUR^®-Sufentanil. DURECT's
proprietaryoral, transdermal and injectable depot delivery technologies
enable new indications and superior clinical/commercial attributes such as
abuse deterrence, improved convenience, compliance, efficacy and safety for
small molecule and biologic drugs. For more information, please visit
www.durect.com.

DURECT Forward-Looking Statement

The statements in this press release regarding the potential uses, benefits,
commercial opportunity and possible market of Relday, extension of the Relday
Phase 1 study to include a 100 mg dose of the same formulation in order to
enable evaluation of dose proportionality across the full dose range that
would be anticipated to be used in clinical practice, the expectation of
completing the extension of this Phase 1 clinical trial during the second
quarter of 2013, and the anticipation that an NDA will be filed for POSIDUR in
the first quarter of 2013 are forward-looking statements involving risks and
uncertainties that can cause actual results to differ materially from those in
such forward-looking statements. Potential risks and uncertainties include
but are not limited to, DURECT's or Zogenix's difficulty or failure to obtain
approvals from regulatory agencies with respect to clinical trials and other
development activities, or their respective abilities to design, enroll,
conduct and complete clinical trials, failure of such clinical trials to
produce intended results, delays of Zogenix's Phase 1 clinical trial
extension, unfavorable safety or PK results, possible adverse events
associated with the use of Relday, delays and costs due to additional work or
other requirements imposed by regulatory agencies for continued development of
POSIDUR or development, approval or sale of Relday, interruptions of supplies
of key components of Relday or POSIDUR, our ability to complete the design,
development and manufacturing process development of Relday, and to
manufacture, commercialize and obtain marketplace acceptance of Relday, and
avoid infringing patents held by other parties and secure and defend patents
of our own, and manage and obtain capital to fund our growth, operations and
expenses. You should not place undue reliance on these forward-looking
statements, which apply only as of the date of this press release. Additional
risks and uncertainties relating to DURECT and its business can be found under
the heading "Risk Factors" in DURECT quarterly report on Form 10-Q for the
quarter ended September 30, 2012 and other filings with the SEC. DURECT does
not undertake any obligation to update forward-looking statements and
expressly disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained herein to
reflect any change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any statements are based.

NOTE: POSIDUR^™, SABER^®, ORADUR^®, TRANSDUR^®, and ELADUR^™ are trademarks of
DURECT Corporation. Other referenced trademarks belong to their respective
owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates
under development and have not been approved for commercialization by the U.S.
Food and Drug Administration or other health authorities.

SOURCE DURECT Corporation

Website: http://www.durect.com
Contact: Matthew J. Hogan, Chief Financial Officer, DURECT, +1-408-777-4936
 
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