DURECT Corporation Announces Initiation of Phase III Studies for Remoxy, a Novel Oral Pain Medication using the ORADUR(TM) Gel-Cap

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CUPERTINO, Calif., Dec. 23 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX), an emerging specialty pharmaceutical systems company,
announced today the initiation of Phase III clinical testing for Remoxy(TM), a
novel long-acting, abuse-deterrent oral formulation of oxycodone based on
DURECT’s ORADUR(TM) technology licensed to Pain Therapeutics, Inc. On June 29,
2004, Pain Therapeutics announced the results of studies conducted in human
volunteers in the United Kingdom to confirm Remoxy’s anti-abuse properties and
to assess the drug’s pharmacokinetics. On December 6, 2004, in a subsequent
study, Pain Therapeutics announced the results of a head-to-head comparison of
the abusability of Remoxy versus Oxycontin(R), a brand name narcotic
painkiller with annual sales exceeding $1.9 billion.

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“This represents a significant milestone for our ORADUR franchise and we
are very pleased with the rapid progress by which this partnered program has
advanced into late stage clinical development. Thus far, these clinical
results reinforce our belief that products developed with our ORADUR sustained
release oral gel-cap technology may offer a variety of benefits, including the
potential to reduce abuse when compared to current long-acting dosage forms
that are on the market today,” stated James E. Brown, DVM, President and CEO
of DURECT. “Beyond our partner Pain Therapeutics, we have ongoing feasibility
activities utilizing our ORADUR and look forward to expanding our
relationships with a number of pharmaceutical companies to develop additional
innovative sustained release oral gel-cap products that utilize select opioids
and other potentially abused active agents.”

The positive results of the Remoxy clinical studies reported to date were
attributed to the unique characteristics of the ORADUR sustained released oral
gel-cap technology. 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) or sucrose acetate isobutyrate (SAIB), to provide
controlled 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.

About Remoxy

Remoxy is an oral, long-acting oxycodone capsule under development by Pain
Therapeutics, 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 joint development and license
agreement. Oxycodone is also the active drug ingredient in OxyContin, a brand
name narcotic painkiller with annual sales exceeding $1.9 billion. ORADUR is a
patented technology based on sucrose acetate isobutyrate, a high-viscosity,
biodegradable liquid matrix that forms the basis for a number of different
injectible depot and oral gel-cap drug candidates, including Remoxy. 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 certain other opioid drugs formulated with DURECT’s ORADUR
technology. 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 product sales.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceuticals systems
company focused on the development of pharmaceutical systems based on its
proprietary drug delivery platform technologies that treat chronic
debilitating diseases and enable biotechnology products. These platform
technologies include the SABER(TM) Delivery System (a patented and versatile
depot injectable useful for protein and small molecule delivery), the
ORADUR(TM) sustained release oral gel-cap technology (an oral sustained
release technology with several potential abuse deterrent properties), the
DURIN(TM) Biodegradable Implant (drug-loaded implant system) and the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system).
DURECT also partners with pharmaceutical companies to develop and
commercialize proprietary and enhanced pharmaceutical products based on its
technologies. DURECT has five disclosed on-going development programs of which
three are in collaboration with pharmaceutical partners. Additional
information about DURECT is available at www.www.durect.com.

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

The statements in this press release regarding DURECT’s and Pain
Therapeutics’ products in development and product development plans 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 Pain Therapeutics’ abilities to complete the design, development,
and manufacturing process development of its products, manufacture and
commercialize its products, obtain product and manufacturing approvals from
regulatory agencies, manage its growth and expenses, manage relationships with
third parties, finance its activities and operations, as well as marketplace
acceptance of these products. Further information regarding these and other
risks is included in DURECT’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2003 filed with the SEC on March 11, 2004, DURECT’s
Quarterly Report on Form 10Q and other periodic reports filed with the SEC
under the heading “Factors that may affect future results.”
Remoxy(TM) and other products mentioned above are under development and have
not been submitted or approved for commercialization by the US Food and Drug
Administration or other health authorities.


Schond L. Greenway
Executive Director, IR and Strategic
Planning, of DURECT Corporation,
Stephanie C. Diaz
415-885-2298, sdiaz@vidaLLC.com,
Tim Brons (media),

646-319-8981, tbrons@vidaLLC.com,
both of Vida Communication, for DURECT

/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
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/Web site: http://www.www.durect.com /
12/23/2004 12:55 EST http://www.prnewswire.com

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