CUPERTINO, Calif., May 5 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) reported today that a pivotal Phase III program has been
initiated for Remoxy(TM), an abuse-resistant pain medicine under development
based on DURECT’s patented ORADUR(TM) technology incorporating the opioid
oxycodone. The event was announced on May 4 by Pain Therapeutics, Inc.
(Nasdaq: PTIE), DURECT’s licensee of the rights to Remoxy and other
ORADUR-based products incorporating oxycodone and three other opioid
compounds. According to Pain Therapeutics, the Remoxy pivotal Phase III
program benefits from a Special Protocol Assessment from the FDA and about 20
clinical sites across the U.S. are now initiated for the Remoxy study.
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“We are very pleased with development progress of Remoxy, and if approved,
look forward to its commercialization by King Pharmaceuticals, Inc. We are
also delighted with the continued advancement of our ORADUR technology
platform,” said James E. Brown, D.V.M., President and CEO of DURECT. “Our
ORADUR platform has the potential to be the basis of numerous other innovative
products given its unique combination of sustained-release and abuse-resistant
properties. We look forward to developing additional sustained release oral
gel-cap products containing active agents prone to abuse.”
ORADUR sustained released oral gel-cap technology provides the unique
characteristics of Remoxy and the referenced follow-on products. 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 products.
Remoxy is an oral, long-acting oxycodone capsule under development by Pain
Therapeutics, Inc. and King Pharmaceuticals, Inc. that incorporates several
abuse-deterrent properties and offers the convenience of twice-a-day dosing.
Remoxy is 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 to King Pharmaceuticals.
Oxycodone is the active drug ingredient in Remoxy and in the branded product
OxyContin(R). OxyContin(R), the leading brand name opioid used in the
treatment of moderate-to-severe pain, has U.S. sales of $1.9 billion for the
year ended December 2004. Drug abusers can easily extract oxycodone from
OxyContin(R) tablets in order to induce a quick and powerful euphoric high.
Oxycodone abusers risk respiratory depression, which can be fatal, and opioid
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.
Forward Looking Statement
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 Annual Report on Form 10-K for the year ended December
31, 2005 filed with the SEC on March 16, 2006 under the heading “Risk
NOTE: SABER(TM) and ORADUR(TM) are trademarks of DURECT Corporation.
Other referenced trademarks belong to their respective owners.
SOURCE DURECT Corporation -0- 05/05/2006 /CONTACT: Schond L. Greenway, Vice President, Investor Relations and Strategic Planning of DURECT Corporation, +1-408-777-1417/ /Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO AP Archive: http://photoarchive.ap.org PRN Photo Desk, firstname.lastname@example.org/ /Web site: http://www.www.durect.com/ (DRRX PTIE) CO: DURECT Corporation; Pain Therapeutics, Inc. ST: California IN: MTC HEA SU: TRI LIC SF-TH -- SFF009 -- 4121 05/05/2006 06:30 EDT http://www.prnewswire.com