DURECT Announces FDA Acceptance of New Drug Application (NDA) Submission for POSIDUR® (SABER®-Bupivacaine)

 DURECT Announces FDA Acceptance of New Drug Application (NDA) Submission for
                        POSIDUR® (SABER®-Bupivacaine)

PR Newswire

CUPERTINO, Calif., June 20, 2013

CUPERTINO, Calif., June 20, 2013 /PRNewswire/ --DURECT Corporation (Nasdaq:
DRRX) today announced that the New Drug Application (NDA) for the
investigational product POSIDUR (SABER-Bupivacaine) has been accepted by the
U.S. Food and Drug Administration (FDA) indicating that the application is
sufficiently complete to permit a substantive review. 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. The Prescription Drug User Fee Act (PDUFA) goal date (the date
the FDA expects to complete its review of the NDA) has been confirmed as
February 12, 2014.

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"We're extremely pleased that this NDA submission has been accepted for review
and that our PDUFA date is now less than eight months away.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."

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, possible 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, the risk that the
FDA will not complete review of the NDA by the PDUFA date, potential adverse
effects arising from additional 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-Q on May 3, 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, +1-408-777-4936
 
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