CUPERTINO, Calif., June 29 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today the preliminary results of
its Phase II clinical trial for its lead product, a 3-month continuous
infusion subcutaneous implant for the treatment of chronic pain. The product,
previously referred to as DUROS sufentanil, has been given the product name
Chronogesic(TM). The preliminary results of the Phase II study are being
presented to leading pain clinicians from around the world at the 2nd World
Congress of the World Institute of Pain held June 27-30, in Istanbul, Turkey.
Preliminary results from the Phase II study showed that patients had
clinically significant improvement in pain control and had reductions in some
opioid side effects when treated with Chronogesic compared to the patients’
previous opioid therapies. A full analysis of the Phase II data is currently
underway and the complete findings will be available upon completion of Phase
II study analysis.
This Phase II clinical trial was designed to determine the dose conversion
strategy from other approved opioid medications to Chronogesic, and to
evaluate the safety and efficacy of the Chronogesic therapy. The study
enrolled adults ranging in age from 26 to 68 at 9 clinical sites. The study
included patients whose chronic pain is stable and opioid responsive (daily
opioid requirements of 100-1,000 mg of oral morphine equivalents) and results
from a variety of malignant and non-malignant causes. The blinded randomized
crossover portion of the study was designed to address conversion from other
opioids to Chronogesic, followed by an open-label portion where Chronogesic
was implanted in patients for up to 6 weeks, and safety and efficacy assessed.
“We believe Chronogesic, which is designed to provide 3 months of
continuous relief for chronic pain patients, represents a significant
advancement in pain therapy and adds a valuable tool to the treatment options
for chronic pain patients,” stated Dr. Dennis Fisher, Vice President of
Medical Affairs and Medical Director of DURECT. “The preliminary outcomes from
this study are consistent with the positive reaction of physicians about our
product, as demonstrated by completion of patient enrollment for this study in
less than three months and three months ahead of schedule. Most of the
physicians from our Phase II trial and numerous investigators from around the
world have expressed strong interest in participating in our upcoming Phase
III trials.”
“These preliminary results support our belief that Chronogesic has the
potential to be a more convenient, patient-friendly product that may provide
an alternative to current therapies for the long term treatment of stable and
opioid responsive chronic pain,” stated James E. Brown, CEO of DURECT.
DURECT Corporation is pioneering the development and commercialization of
pharmaceutical systems to deliver the right drug to the right site in the
right amount at the right time. DURECT’s pharmaceutical systems combine
technology innovations from the medical device and drug delivery industries
with proprietary pharmaceutical and biotechnology drug formulations. These
capabilities can enable new drug therapies or optimize existing therapies
based on a broad range of compounds, including small molecule pharmaceuticals
as well as biotechnology molecules such as proteins, peptides and genes.
Founded in 1998, DURECT is headquartered in Cupertino, CA. The company’s
World Wide Web site can be accessed at http://www.www.durect.com. The company’s
World Wide Web site for ALZET osmotic pumps, IntraEAR and Southern BioSystems,
Inc. can be accessed at http://www.alzet.com, http://wsww.intraear.com and
http://www.southernbiosystems.com, respectively. To join DURECT’s email alert
service, please register by selecting “Email Alerts” on the main Investor
Relations web page at http://www.www.durect.com.
Chronogesic(TM) is a trademark of DURECT Corporation. IntraEAR(R) is a
registered trademark of DURECT Corporation. SABER(TM) is a trademark of
Southern BioSystems, Inc., a subsidiary of DURECT Corporation.
The statements in this press release regarding DURECT’s products in
development, product development plans or expected results, or expected
product benefits, are forward-looking statements involving risks and
uncertainties that could 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 develop, manufacture and
commercialize its products, successfully complete clinical trials, obtain
product and manufacturing approvals from regulatory agencies, and validate and
qualify a manufacturing facility, as well as marketplace acceptance of
DURECT’s products. Further information regarding these and other risks is
included in the company’s S-1 registration statement, filed with the SEC on
September 22, 2000, 424(b) prospectus filed with the SEC on September 28,
2000, Quarterly Report on Form 10Q for the quarter ended March 31, 2001 filed
with the SEC on May 11, 2001 and Annual Report on Form 10K for the fiscal year
ended December 31, 2000 filed with the SEC on March 30, 2001.
| Contact: | Schond L. Greenway, Director, Investor Relations of DURECT |
|---|---|
| Corporation, 408-777-1417, schond.greenway@durect.com. |
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SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Director, Investor Relations of DURECT
Corporation, 408-777-1417, schond.greenway@durect.com/