CUPERTINO, Calif., Sept. 9 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX), an emerging specialty pharmaceutical company, announced today
that Pain Therapeutics, Inc. has achieved positive Phase III clinical results
for Remoxy(TM), a novel long-acting, abuse-deterrent oral formulation of
oxycodone based on DURECT’s ORADUR(TM) technology being developed under
license from DURECT.
“These results represent 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. “We continue working 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.”
Phase III Study Design and Results
The randomized, double-blinded study was designed to compare the safety
and efficacy of Remoxy against placebo in osteoarthritic patients with
moderate-to-severe chronic pain. Over 209 patients were enrolled in over
20 U.S. clinical sites. Patients were treated with Remoxy 20 mg or matching
placebo twice daily over a 4-week study period. The results announced by Pain
Therapeutics demonstrated a statistically significant percent decrease in pain
scores for patients using Remoxy as compared to placebo, as measured by a
standard Likert Pain Scale. Patients also reported a statistically significant
difference in quality of life using Remoxy as compared to placebo, as measured
by as measured by a standard SF-12 Health Survey and in patients’ self-
reported Quality of Analgesia. No drug-related safety issues were noted in the
study, and as expected opioid-related adverse events (including
nausea/vomiting, dizziness, pruritis (itching) and somnolence/sedation) and
drop-out rates were higher in the Remoxy arm compared to placebo. Pain
Therapeutics intends to initiate a second Phase III registration study by
year-end 2005.
Remoxy draws upon 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 pharmaceutical 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), the TRANSDUR(TM) transdermal technology and the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system).
DURECT also collaborates 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
four are in collaboration with pharmaceutical partners. Additional information
about DURECT is available at http://www.www.durect.com.
NOTE: SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and MICRODUR(TM) are
trademarks of DURECT Corporation. Other referenced trademarks belong to their
respective owners.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT’s products in
development, anticipated product benefits and clinical trial 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 ability to complete the design, development, and manufacturing
process development of the product candidate and obtain approvals from
regulatory agencies to manufacture the product candidate, as well as Pain
Therapeutics’ ability to initiate, enroll and complete clinical trials and
obtain product approvals from regulatory agencies to commercialize the product
candidate, and 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 June 30, 2005 filed with the SEC on
August 4, 2005 under the heading “Factors that may affect future results.”
SOURCE DURECT Corporation
09/09/2005
/CONTACT: Schond L. Greenway, Executive Director, Investor Relations and
Strategic Planning of DURECT Corporation, 408-777-1417/