Primary Endpoint of Pivotal Phase III Clinical Trial Achieved for Remoxy(TM)

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CUPERTINO, Calif., Dec. 6 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today that the pivotal Phase III trial for Remoxy had
successfully met its primary endpoint (p<0.01) that was prospectively defined
by the U.S. Food and Drug Administration (FDA) during the Special Protocol
Assessment process. Remoxy, an investigational drug based on DURECT’s
patented ORADUR(TM) technology, is an abuse-deterrent version of long-acting
oxycodone, a powerful painkiller available only by prescription. Remoxy is
intended to meet the needs of physicians or pharmacists who appropriately
prescribe or dispense long-acting oxycodone and who seek to minimize the risks
of abuse, misuse or diversion. These successful results were reported today
by Pain Therapeutics (Nasdaq: PTIE) and King Pharmaceuticals (NYSE: KG); Pain
Therapeutics is DURECT’s licensee of the rights to this investigational drug,
and they in turn have sublicensed the commercialization rights to King
Pharmaceuticals. According to Pain Therapeutics and King Pharmaceuticals, the
FDA has agreed in writing that a single Phase III pivotal study is needed to
support the regulatory approval of Remoxy. As a result, Pain Therapeutics has
stated that they expect to file a New Drug Application for Remoxy in Q2 2008.

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“These positive clinical trial results represent a major validating
milestone for the ORADUR technology which has the potential to serve as a
platform for multiple drugs that require controlled release in an abuse
deterrent form, and it takes us one step closer to the first NDA filing based
on our ORADUR technology,” stated James E. Brown, DVM, President and CEO of
DURECT. “The abuse of pain medications is a widespread problem in this
country and addressing that issue is clearly in the public interest.”

Pivotal Remoxy Phase III Study (as reported by Pain Therapeutics and King


This pivotal Phase III randomized, double-blinded, placebo-controlled,
multi-center study was designed to evaluate the analgesic efficacy of twice-
daily Remoxy versus placebo over a 12-week treatment period. The study
randomized 412 male and female patients. All patients were diagnosed with
osteoarthritis of the knee or hip, as evidenced by x-ray and clinical criteria
of the American College of Rheumatology. Additionally, all patients had pain
intensity scores corresponding to moderate-to-severe pain.

Following informed consent, wash-out and dose titration, patients were
randomized (1:1) into a double-blinded treatment period (12 weeks). During
treatment, patients received twice-daily Remoxy or matching placebo. The
total drug dose per patient per day ranged from 10-80mg. Pain intensity
scores were assessed on a Likert pain scale. Concomitant pain medications or
rescue medications were not allowed at any point during the 12-week treatment

This Remoxy study received a Special Protocol Assessment (SPA) from the
FDA. With an SPA, the study design, endpoints and statistical analyses needed
to support approval were agreed upon by the FDA prior to initiating the study
and are considered binding.


Pursuant to an SPA, the primary endpoint was defined as mean decrease in
pain intensity scores between Remoxy and placebo during the 12-week treatment
period. Top-line data indicates that the study achieved a statistically
significant result in its primary endpoint (p<0.01). In addition, the study
achieved statistically significant results in secondary endpoints such as
Quality of Analgesia (p<0.01) and Global Assessment (p<0.01). No drug-related
safety issues were noted in this study.


ORADUR is a patented technology designed to transform drugs into sustained
release oral products with the added benefit of being less prone to abuse.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company
developing pharmaceutical systems based on its proprietary drug delivery
platform technologies. The Company currently has multiple late-stage
pharmaceutical products in development addressing large markets in pain
management, with a number of research programs underway targeting chronic
disease and other therapeutic areas. For more information, please visit

NOTE: ORADUR(TM) is a trademark of DURECT Corporation. Other referenced
trademarks belong to their respective owners. Remoxy is a drug candidate
under development and has not been submitted or approved for commercialization
by the FDA or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding Remoxy, its expected New
Drug Application filing date, attributes and commercial potential, and other
potential ORADUR-based products 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, difficulties or delays in development,
testing, regulatory approval, production and marketing of Remoxy and other
potential ORADUR-based products, unexpected delays in the filing of a New Drug
Application for Remoxy with the FDA, unexpected adverse side effects or
inadequate therapeutic efficacy of Remoxy or other potential ORADUR-based
products that could slow or prevent product approval or market acceptance
(including the risk that current and past results of clinical trials are not
necessarily indicative of future results of clinical trials), the uncertainty
of patent protection for Remoxy and other potential ORADUR-based products and
unanticipated research and development and other costs. Further information
regarding these and other risks is included in DURECT’s Form 10-Q dated
November 8, 2007 under the heading “Risk Factors.”

CONTACT: Matthew J. Hogan, Chief Financial Officer of DURECT
Corporation, +1-408-777-4936; or Jeremiah Hall, Senior Vice President of
Feinstein Kean Healthcare, +1-415-677-2700,, for
DURECT Corporation
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