ORADUR(TM) Technology Milestone: New ORADUR-based Investigational Drug Candidate Commences Phase I Clinical Program

Download PDF:

CUPERTINO, Calif., Aug 02, 2006 /PRNewswire-FirstCall via COMTEX News Network/ — DURECT Corporation
(Nasdaq: DRRX) reported today the initiation of a Phase I clinical trial for a
new ORADUR-based opioid drug candidate. 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. According to Pain Therapeutics and
King Pharmaceuticals, the investigational new drug (IND) application for this
new drug candidate has been accepted by the U.S. Food and Drug Administration
(FDA). The active pharmaceutical drug in the new ORADUR-based opioid drug
candidate has not been disclosed.

(Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )

“We are very 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,” stated James
E. Brown, DVM, President and Chief Executive Officer. “Furthermore, we look
forward to developing additional innovative sustained release oral gel-cap
products that utilize other opioids and other active agents prone to abuse.”


ORADUR sustained released oral gel-cap technology provides the unique
characteristics of Remoxy and the other opioid drug candidates subject to the
Pain Therapeutics and King Pharmaceuticals alliance. Products based on the
ORADUR technology can take the form of an easy to swallow gelatin capsule that
uses a high-viscosity base component, SABER(TM), to provide sustained release
of active ingredients for a period of from 12 to 24 hours of drug delivery.
Oral dosage forms based on the ORADUR gel-cap may also have the added benefit
of being less prone to abuse than other controlled release dosage forms on the
market today. ORADUR-based products can be manufactured by a simple process
using conventional methods making them readily scalable. These properties have
the potential to make ORADUR-based products an attractive option for
pharmaceutical companies that seek to develop tamper and abuse resistant oral

About the Collaborations

On November 10, 2005, King Pharmaceuticals, Inc. and Pain Therapeutics,
Inc. announced that the companies have entered into a strategic alliance to
develop and commercialize Remoxy, an oral, long-acting, abuse-resistant
oxycodone capsule, and other ORADUR-based abuse-resistant products using three
other opioid drugs. The products under this collaboration are formulated with
DURECT Corporation’s ORADUR technology under a development and license
agreement between DURECT and Pain Therapeutics. Under the terms of the license
agreement between Pain Therapeutics and DURECT, Pain Therapeutics has
exclusive worldwide rights to develop and to commercialize Remoxy and other
ORADUR-based products using oxycodone and three other opioid drugs. DURECT is
reimbursed for formulation and other work performed under its agreement with
Pain Therapeutics, and will receive milestone payments based on the
achievement of certain technical, clinical or regulatory milestones, in
addition to receiving royalties on end product sales. Pain Therapeutics has
sublicensed the commercialization rights of Remoxy and other ORADUR-based
opioid products to King Pharmaceuticals. Oxycodone is the active drug
ingredient in Remoxy and in the branded product OxyContin(R), a leading brand
name opioid used in the treatment of moderate-to-severe pain.


DURECT Corporation is an emerging specialty pharmaceutical company focused
on the development of pharmaceutical systems based on its proprietary drug
delivery platform technologies. The company is developing pharmaceutical
systems to deliver the right drug to the right place in the right amount at
the right time to treat chronic and episodic diseases and conditions.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT’s and our
collaborators’ investigational products, development and clinical trial plans,
commercial potential and possible economic returns 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 successfully design, enroll,
conduct and complete clinical trials, complete the design, development, and
manufacturing process development of the product candidate, obtain product 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 Quarterly Report on Form 10-Q for the quarter ended
March 31, 2006 filed with the SEC on May 10, 2006 under the heading “Risk

NOTE: SABER(TM) and ORADUR(TM) are trademarks of DURECT Corporation.
Other referenced trademarks belong to their respective owners.


Schond L. Greenway, Vice President, Investor Relations and Strategic Planning of
DURECT Corporation, +1-408-777-1417


Scroll to Top