CUPERTINO, Calif., Nov. 1 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced during its third quarter financial
results conference call yesterday that the company has commenced its Phase III
program for Chronogesic(TM), for the treatment of chronic pain. The primary
objectives of the Phase III program are to continue to demonstrate that the
product is safe, that patients can be transitioned from use of a variety of
existing opioids such as pills and patches to use of Chronogesic(TM) and that
the product is effective and provides pain relief at least equivalent to the
patient’s existing pain therapy.
The focus of the recently completed Phase II trial was to determine the
relative potency of fentanyl, the active agent in Duragesic(R) as compared to
sufentanil, the active agent in Chronogesic(TM). This trial determined that
sufentanil was 7.5 times more potent than fentanyl. In order to convert
patients from their existing opioid to Chronogesic(TM), DURECT plans to
leverage the extensive experience already available on how to transition
patients from use of a variety of opioids to Duragesic(R). The initial focus
of DURECT’s Phase III clinical development efforts is to confirm the method
developed from the Phase II trial to transition patients from Duragesic(R) to
Chronogesic(TM).
In keeping with this initial focus, DURECT announced that it has completed
the clinical portion of a pilot Phase III study to evaluate the procedures
necessary to safely transition patients from Duragesic(R) to Chronogesic(TM).
Data analysis from this trial is ongoing, and a preliminary report of the
results is expected early in 2002.
“We are excited to report that we have started our Phase III program and
we continue to aggressively make progress towards initiation of pivotal Phase
III clinical trials,” stated James Brown, CEO of DURECT. “During the Phase II
trial for Chronogesic(TM), patients reported that Chronogesic(TM) provided
better pain control and fewer side effects, resulting in a strong preference
by patients for Chronogesic(TM) versus other medicines used prior to the
study. We believe that Chronogesic(TM) offers patients a better
quality-of-life alternative to currently available therapies for the long-term
treatment of stable and opioid responsive chronic pain.”
There will be an audio archive available of DURECT’s Third Quarter 2001
Earnings Conference Call on DURECT’s website at http://www.www.durect.com under
the Audio Archive section of “Investor Relations.”
DURECT Corporation 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 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. DURECT focuses on the treatment of
chronic diseases including pain, CNS disorders, cardiovascular disease and
cancer. DURECT holds an exclusive license from ALZA Corporation to develop and
commercialize products in selected fields based on the DUROS(R) implant
technology. Chronogesic(TM), a 3-month continuous infusion subcutaneous
implant for the treatment of chronic pain, is the first product in this series
and completed phase II testing in June 2001. DURECT also owns three
proprietary erodible implant platform technologies, including SABER(TM)
(a patented and versatile depot injectable useful for protein delivery),
microspheres and drug-loaded implants. DURECT also commercializes IntraEAR(R)
catheters, which have been used by physicians to treat inner ear disorders.
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 . 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 .
| NOTE: | Chronogesic(TM), SABER(TM) and IntraEAR(R) are trademarks of DURECT |
|---|---|
| Corporation. DUROS(R) is a trademark of ALZA Corporation. Duragesic(R) is a | |
| registered trademark of Janssen Pharmaceutica Products, L.P. |
The statements in this press release regarding DURECT’s clinical trials,
anticipated results, products in development, expected product benefits,
product development plans or potential product markets 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
successfully complete clinical trials, research, develop, manufacture and
commercialize its products, obtain product and manufacturing approvals from
regulatory agencies, validate and qualify a manufacturing facility and manage
its growth and expenses, as well as marketplace acceptance of DURECT’s
products. Further information regarding these and other risks is included in
DURECT’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2001
filed with the SEC on August 14, 2001, and Annual Report on Form 10-K for the
fiscal year ended December 31, 2000 filed with the SEC on March 30, 2001,
under the heading “Factors that may affect future results.”
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417, or
schond.greenway@durect.com/