DURECT Receives Complete Response Letter from FDA for POSIDUR™ (SABER®-Bupivacaine)

        DURECT Receives Complete Response Letter from FDA for POSIDUR™
                             (SABER®-Bupivacaine)

Company will Host Conference Call on February 13, 2014

PR Newswire

CUPERTINO, Calif., Feb. 12, 2014

CUPERTINO, Calif., Feb. 12, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq:
DRRX) today announced that the U.S. Food and Drug Administration (FDA) has
issued a Complete Response Letter for POSIDUR^™ (SABER^®-Bupivacaine), an
investigational drug for administration into the surgical site to produce
post-surgical analgesia. Based on its review, the FDA has determined that
they cannot approve the NDA in its present form, stating the NDA does not
contain sufficient information to demonstrate that POSIDUR is safe when used
in the manner described in the proposed label, and the FDA has indicated that
additional clinical safety studies need to be conducted. DURECT is evaluating
the issues described in the Complete Response Letter and plans to have further
discussions with the FDA around them.

(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)

"In the coming months, we intend to work with the FDA to gain more clarity on
the next steps that would be required to address the issues cited in the
Complete Response Letter," stated James E. Brown, DVM, President and CEO of
DURECT Corporation.

Conference Call and Webcast

A live audio webcast of a conference call will be broadcast over the internet
at 8:30 a.m. Eastern Time on February 13 and is available by accessing
DURECT's homepage at www.durect.com and clicking "Investor Relations." If you
are unable to participate during the live webcast, the call will be archived
on DURECT's website under Audio Archive in the "Investor Relations" section.

About POSIDUR

POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented
SABER^® technology to deliver bupivacaine to provide up to three days of pain
relief after surgery. We are in discussions with potential partners regarding
licensing development and commercialization rights to POSIDUR, for which we
hold worldwide rights. 

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 POSIDUR, the potential benefits
and uses of POSIDUR, our on-going review and interactions with the FDA
regarding approval of the POSIDUR NDA and the potential of resolving all
outstanding regulatory concerns regarding POSIDUR 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, the risk of adverse
decisions by the FDA or other regulatory agencies, including product
non-approval, delays and additional costs due to requirements imposed by the
FDA or regulatory agencies, the risk that we may not be able to adequately
address all of FDA's concerns regarding the POSIDUR NDA or there could be a
delay in addressing such concerns, the potential that FDA may not grant
regulatory approval of POSIDUR, the risk of potential adverse effects arising
from additional testing or use of POSIDUR, and the potential that the data
that we have generated or may generate may not be deemed sufficient by FDA or
other regulatory agencies to support regulatory approval of POSIDUR. Further
information regarding these and other risks is included in DURECT's Form 10-Q
on November 5, 2013 under the heading "Risk Factors."

NOTE: POSIDUR^™, SABER^®, TRANSDUR^®, and ELADUR^™ are trademarks of DURECT
Corporation. 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 408-777-4936
 
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