CUPERTINO, Calif., July 11 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) today reported that patient recruitment has been completed in
the pivotal Phase III study with Remoxy(TM), an abuse resistant pain medicine
under development based on DURECT’s patented ORADUR(TM) technology
incorporating the opioid oxycodone. This event was announced today by Pain
Therapeutics, Inc. (Nasdaq: PTIE) and King Pharmaceuticals (NYSE: KG); Pain
Therapeutics is DURECT’s licensee of the rights to this drug candidate and
they in turn have sublicensed the commercialization rights to King
Pharmaceuticals.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)
This randomized, double-blinded, placebo-controlled study enrolled
patients in the U.S. with moderate-to-severe osteoarthritic pain. Following a
titration period, patients were randomized to either twice-daily Remoxy (10-80
mg daily) or placebo for 12 weeks. The primary endpoint is change in pain
scores during the treatment period. According to Pain Therapeutics and King
Pharmaceuticals, this Remoxy study is being conducted under the auspices of a
Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration
(FDA) and top line results of this study are expected in the fourth quarter of
2007, after the last patient completes the three-month treatment period.
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 a number of 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
http://www.www.durect.com.
NOTE: ORADUR(TM) is a trademark of DURECT Corporation. Other referenced
trademarks belong to their respective owners. Remoxy is under development and
has not been submitted or approved for commercialization by the US Food and
Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding Remoxy, its potential
attributes and expected clinical trials results 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, DURECT, Pain Therapeutics and
King Pharmaceutical’s abilities to design, conduct and complete clinical
trials, obtain successful results from such clinical trials, complete the
design, development, and manufacturing process development of the product
candidate, obtain regulatory and manufacturing approvals from regulatory
agencies and manufacture and commercialize the product candidate, as well as
marketplace acceptance of the product candidate. Further information regarding
these and other risks is included in DURECT’s Form 10-Q dated May 9, 2007
under the heading “Risk Factors.”
SOURCE DURECT Corporation
07/11/2007
CONTACT: Matthew J. Hogan, Chief Financial Officer of DURECT
Corporation, +1-408-777-4936, mhogan@durect.com; or Jeremiah Hall, Senior Vice
President of Feinstein Kean Healthcare, +1-415-677-2700,
jeremiah.hall@fkhealth.com, for DURECT Corporation
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
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PRN Photo Desk, photodesk@prnewswire.com
Web site: http://www.www.durect.com