DURECT Announces Submission of New Drug Application for POSIDUR™ (SABER®-Bupivacaine)

       DURECT Announces Submission of New Drug Application for POSIDUR™
                             (SABER®-Bupivacaine)

PR Newswire

CUPERTINO, Calif., April 16, 2013

CUPERTINO, Calif., April 16, 2013 /PRNewswire/ --DURECT Corporation (Nasdaq:
DRRX) today announced the submission of a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for the investigational product
POSIDUR (SABER^®-Bupivacaine). POSIDUR is a post-operative pain relief depot
that utilizes DURECT's patented SABER technology to deliver bupivacaine and is
designed to provide up to three days of pain relief after surgery. DURECT
submitted the NDA as a 505(b)(2) application.

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

"We're extremely pleased to submit this NDA for POSIDUR to the FDA. If
approved by the FDA, POSIDUR will provide a non-opioid alternative treatment
option for post-surgical pain," James E. Brown, D.V.M., President and CEO of
DURECT, stated, "Treating post-surgical pain with a true long-acting local
anesthetic has the potential benefit of reducing the need for opioids and
their associated systemic side effects that can prolong the time to recovery
and result in extended hospital stays."

We expect that the FDA will notify us whether our NDA submission has been
accepted for filing within 74 days of submission, which the FDA bases on their
initial 60-day review of the completeness of our application. If accepted for
filing, the FDA would be expected to assign a PDUFA date of 10 months after
the submission.

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, submission of the NDA
to the FDA and possible acceptance and/or approval of the NDA by the FDA, the
potential benefits and uses of POSIDUR and discussions with potential partners
regarding licensing 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 regulatory agencies,
including product non-approval, delays and additional costs due to
requirements imposed by regulatory agencies, potential adverse effects arising
from the testing or use of POSIDUR, the potential that the data that we have
generated may not be deemed sufficient by FDA or other regulatory agencies to
support regulatory approval of POSIDUR, our potential inability to license
rights to POSIDUR on commercially acceptable terms, or at all, and the risk of
obtaining marketplace acceptance of POSIDUR, avoiding infringing patents held
by other parties and securing and defending patents of our own, and managing
and obtaining capital to fund our growth, operations and expenses. Further
information regarding these and other risks is included in DURECT's Form 10-K
on March 1, 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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