CUPERTINO, Calif., July 6 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced the advancement of its ORADUR(TM) sustained release
oral gel-cap technology (formerly referred to as the SABER(TM) oral gel-cap
technology) with positive human clinical results for Remoxy(TM). Remoxy is a
novel long-acting oral formulation of oxycodone based on DURECT’s ORADUR
technology under development by Pain Therapeutics, Inc., which is targeted to
decrease the potential for drug misuse or abuse. 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.
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“We are very pleased with the progress that Pain Therapeutics has made
thus far with the clinical study results for Remoxy(TM). These 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. “We look forward to working with a variety of pharmaceutical
companies, including Pain Therapeutics, to develop more innovative sustained
release oral gel-cap products using this exciting technology.”
About ORADUR
The results of the Remoxy clinical studies reported 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,
such as 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. 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 (www.www.durect.com) is pioneering the development and
commercialization of pharmaceutical systems for the treatment of chronic
debilitating diseases and enabling biotechnology-based pharmaceutical
products. DURECT’s goal is to deliver the right drug to the right site in the
right amount at the right time. DURECT’s lead product in development is
CHRONOGESIC(R), a 3-month product for the treatment of chronic pain. DURECT
also owns a number of proprietary drug delivery platform technologies,
including 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 (oral drug delivery technology), the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system)
and the DURIN(TM) Biodegradable Implant (drug-loaded implant system) upon
which DURECT is developing a pipeline of other products.
NOTE: CHRONOGESIC(R), SABER(TM), ORADUR(TM), MICRODUR(TM) and DURIN(TM)
are trademarks of DURECT Corporation. Remoxy(TM) is a trademark of Pain
Therapeutics, Inc. All other trademarks referred to belong to their
respective owners.
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.”
CHRONOGESIC 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.
SOURCE DURECT Corporation
/CONTACT: Schond L. Greenway, Executive Director, IR and Strategic
Planning,+1-408-777-1417, of DURECT Corporation /
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