CUPERTINO, Calif., Nov. 30 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) today reported positive results from a Phase I clinical trial
evaluating an abuse-resistant opioid pain drug candidate based on DURECT’s
patented ORADUR(TM) technology. The event was announced on November 29 by Pain
Therapeutics, Inc., DURECT’s licensee of the rights to this drug candidate.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
The Phase I clinical trial was designed to investigate the safety,
tolerability, pharmacokinetics and pharmacodynamic profile of a single, oral
dose of this drug candidate in healthy volunteers. As reported by Pain
Therapeutics, this drug candidate was safe and well-tolerated, and its release
profile appears well suited to use with a chronic pain population; there were
no unexpected adverse events in this trial.
“We are pleased with the results and pace of this Phase I clinical trial,”
stated James Brown, Chief Executive Officer of DURECT. “We are delighted with
the advancement of our ORADUR technology platform and look forward to the
continued progress of all of the products under the King Pharmaceuticals and
Pain Therapeutics alliance.”
This new drug candidate is the second ORADUR-based opioid drug to undergo
clinical testing by King Pharmaceuticals, Inc., the company which will be
commercializing the drug candidate, if approved, and Pain Therapeutics, Inc.,
DURECT’s licensee of the rights to the drug candidate and other ORADUR-based
products incorporating oxycodone and three other opioid compounds. The first
drug candidate under development by Pain Therapeutics and King
Pharmaceuticals, Remoxy (ORADUR-based oxycodone), is currently in Phase III
clinical testing. The active pharmaceutical drug in the new ORADUR-based
opioid drug candidate has not been disclosed.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused
on the development of pharmaceutical systems based on its proprietary drug
delivery platform technologies focused on treating chronic and episodic
diseases and conditions. The Company currently has a number of late-stage
pharmaceutical products in development initially focused on significant unmet
medical needs in pain management, with a number of research programs underway
in a variety of other therapeutic areas. For more information, please visit
www.www.durect.com.
NOTE: ORADUR(TM) is a trademark of DURECT Corporation. Other referenced
trademarks belong to their respective owners. The drug candidate referenced
in this press release and Remoxy are under development and have 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 DURECT’s products in
development and DURECT’s technologies and their potential attributes 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’s (and that of its third party collaborators) abilities to design,
enroll, 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 November 3, 2006 under the heading “Risk
Factors.”
SOURCE DURECT Corporation
11/30/2006
CONTACT: Schond L. Greenway, Vice President, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417; or Media: Jeremiah
Hall, Senior Vice President of Feinstein Kean Healthcare, +1-415-677-2700 or
jeremiah.hall@fkhealth.com, for DURECT Corporation
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Web site: http://www.www.durect.com
(DRRX)