Pfizer Proceeding with REMOXY® Development

                  Pfizer Proceeding with REMOXY® Development

PR Newswire

CUPERTINO, Calif., Oct. 22, 2013

CUPERTINO, Calif., Oct. 22, 2013 /PRNewswire/ --DURECT Corporation (Nasdaq:
DRRX) announced today that Pfizer Inc. (NYSE: PFE) has stated that, having
achieved technical milestones related to manufacturing, they will continue the
development program for REMOXY^® (oxycodone) Extended-Release Capsules CII.
Following guidance received from the U.S. Food and Drug Administration (FDA)
earlier this year, Pfizer announced that they will proceed with the additional
clinical studies and other actions required to address the Complete Response
Letter received in June 2011.These new clinical studies will include, in
part, a pivotal bioequivalence study with the modified REMOXY formulation to
bridge to the clinical data related to the original REMOXY formulation, and an
abuse-potential study with the modified formulation. As previously disclosed,
the complete response submission is not expected to occur prior to mid-2015.

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

"We are pleased that, after a thorough review and having achieved technical
milestones, Pfizer is proceeding with development of REMOXY," stated James
Brown, President and CEO of DURECT. "We continue to believe that REMOXY could
play an important role in serving the needs of chronic pain patients while
potentially reducing the misuse and abuse of oxycodone."

In addition, Pain Therapeutics, Inc. (Nasdaq: PTIE) has regained all rights
from Pfizer with respect to the three other ORADUR-based opioid drug
candidates (hydrocodone, hydromorphone and oxymorphone).Pain Therapeutics is
now free to develop and commercialize these product candidates on its own or
with a licensee. Investigational New Drug (IND) applications for these drug
candidates are in place with the FDA. Pain Therapeutics has stated that they
have not yet made a decision to develop or out-license the three product
candidates.

About REMOXY

REMOXY,  an investigational drug, is a unique long  acting oral formulation of
oxycodone intended to treat moderate-to-severe pain when a continuous,
around-the-clock opioid analgesic is needed for an extended period of time.
Based on DURECT's ORADUR^® technology, which is covered by issued patents and
pending patent applications owned by us, REMOXY is designed to discourage
common methods of tampering associated with prescription opioid analgesic
misuse and abuse.

Corporate Relationships

In December 2002, DURECT licensed to Pain Therapeutics the right to develop
and commercialize on a worldwide basis REMOXY and other oral sustained release
drug candidates using the ORADUR technology which incorporate four specified
opioid compounds. Under the license agreement, DURECT is reimbursed for
formulation and other work performed under its agreement with Pain
Therapeutics, and will receive additional payments if certain development and
regulatory milestones are achieved with respect to the licensed drug
candidates. In addition, if commercialized, DURECT will receive royalties for
REMOXY and the other licensed drug candidates of between 6.0% to 11.5% of net
sales of the drug candidate depending on sales volume as well as a mark-up on
DURECT's supply of key excipients used in the manufacture of the licensed drug
candidates. In 2005, King Pharmaceuticals, Inc. entered into an agreement
with Pain Therapeutics to develop and commercialize REMOXY. Pfizer obtained
rights to REMOXY as part of its acquisition of King Pharmaceuticals in
February 2011.

About DURECT Corporation

DURECT is a specialty pharmaceutica lcompany 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 REMOXY, the continued
development of REMOXY by Pfizer, additional trials and studies, the potential
resubmission of the NDA to the FDA, the potential regulatory approval of
REMOXY by the FDA, and the potential benefits and uses of REMOXY 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 that additional trials and studies will not have satisfactory
outcomes, the risk that Pfizer will discontinue development of REMOXY in the
future, 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 REMOXY, the potential that the data submitted by Pfizer in response to
the complete response letter will not be deemed sufficient by FDA or other
regulatory agencies to support regulatory approval of REMOXY, and the risk of
obtaining marketplace acceptance of REMOXY, 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 August 6, 2013 under the heading "Risk Factors."

NOTE: ORADUR^®, 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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