CUPERTINO, Calif., Mar 18, 2002 /PRNewswire-FirstCall via COMTEX/ — DURECT
Corporation (Nasdaq: DRRX) announced today the results from a pilot Phase III
clinical study for its lead product in development, the CHRONOGESIC(TM)
(sufentanil) Pain Therapy System for the treatment of chronic pain. The
CHRONOGESIC product is undergoing clinical investigation for the treatment of
stable, opioid responsive chronic pain patients in the over $2 billion opioid
market for chronic pain. Chronic pain, defined as lasting 6 months or longer, is
a significant problem associated with chronic diseases, including cancer and
various neurological and skeletal disorders. Chronic nonmalignant pain affects
as many as 34 million Americans annually.
“In our evaluation of 18 patients in this pilot Phase III study, we successfully
converted patients from the Duragesic(R) product to the CHRONOGESIC product
without observing clinically-relevant side effects or adverse events,” stated
Dr. Lowell Reynolds, the investigator for this study conducted at Loma Linda
University Medical Center, Loma Linda, California. “The CHRONOGESIC product
represents a significant advancement in pain therapy, and upon approval, will
add a valuable tool to the treatment options for all pain clinicians.”
Study Rationale
DURECT has developed a clinical strategy to permit safe transition from a
variety of different opioid medications to the CHRONOGESIC product, an osmotic
implant that continuously delivers sufentanil for three months. This strategy
requires that patients, who are presently using a variety of opioid medications
be transitioned initially to a single opioid medication, the Duragesic(R)
product, a 3-day transdermal fentanyl patch. After this brief transition period,
patients then receive the CHRONOGESIC product.
As part of this transition strategy, DURECT will leverage the extensive
experience already available on how to transition patients from a variety of
opioids to the Duragesic product. To convert patients from the Duragesic product
to the CHRONOGESIC product, DURECT had to determine the relative potency of
sufentanil (the active agent in the CHRONOGESIC product) to fentanyl (the active
agent in the Duragesic product). In September 2001, DURECT completed a Phase II
trial that determined that sufentanil was 7.5 times more potent than fentanyl.
The objective of this pilot phase III study was to confirm the potency ratio of
sufentanil to fentanyl, determined in the Phase II study, and that this
transition strategy works to safely transition patients from the Duragesic
product to DURECT’s CHRONOGESIC product.
Overall Study Design and Plan
The study was a single center 6-week trial consisting of patients whose primary
opioid medication was the Duragesic product. Eighteen patients with moderate to
severe chronic pain associated with a variety of malignant and non-malignant
causes participated in the study.
Each patient included in the study underwent the transition process and received
the corresponding CHRONOGESIC therapy based on the potency ratio determined
during the Phase II study. Patients remained on the CHRONOGESIC therapy for up
to six weeks. The primary outcome measures for the pilot Phase III study were
the patient’s pain status and opioid consumption before and after implant of the
CHRONOGESIC product.
Study Results
In the recently completed pilot Phase III study, patients were safely
transitioned from the Duragesic product to the CHRONOGESIC product. During the
6-week implant period, patients were evaluated for overdose and overall opioid
consumption. There was no evidence of patient overdose at any point in time. The
median reduction in opioid consumption other than from the CHRONOGESIC product
(i.e., the fraction of opioid dosing that was replaced by the CHRONOGESIC
product) was 72%.
Patients were also asked about the adequacy of their pain treatment. Seventy
eight percent (78%) of patients reported either an improvement or no change in
their pain scores. Additionally, there were no significant adverse events
related to the CHRONOGESIC product.
Based on the absence of overdose and the substantial replacement of opioid
medications by the CHRONOGESIC product, this pilot Phase III study confirms the
accuracy of the potency ratio determined in the Phase II trial. The study also
demonstrates that patients can be transitioned safely from the Duragesic product
to the CHRONOGESIC product.
Pivotal Phase III Program
The primary objectives of DURECT’s pivotal Phase III program are to demonstrate
that patients can be safely transitioned from a variety of existing opioids,
such as pills and patches, to the CHRONOGESIC product, as well as to demonstrate
that the CHRONOGESIC product provides pain relief at least equivalent to the
patient’s existing pain therapy. The program will include placebo-controlled
safety and efficacy studies in the U.S. Studies will also be conducted to
compare the CHRONOGESIC product to an active control therapy to support European
registration. The program will also include an open-label study to evaluate
re-implant procedures and long-term safety and efficacy.
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. The CHRONOGESIC product, 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
drug delivery platform technologies, including the SABER(TM) Delivery System (a
patented and versatile depot injectable useful for protein delivery), the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system)
and the DURIN(TM) Biodegradable Implant (drug-loaded implant system). DURECT
also commercializes ALZET(R) Osmotic Pumps for research animal use, IntraEAR(R)
catheters which have been used by physicians to treat inner ear disorders and
PLGA based biodegradable polymers.
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.
NOTE: CHRONOGESIC(TM), IntraEAR(R) and ALZET(R) are trademarks of DURECT
Corporation. SABER(TM), MICRODUR(TM) and DURIN(TM) are trademarks of Southern
BioSystems, Inc., a wholly owned subsidiary of DURECT Corporation. DUROS(R) and
is a trademark of ALZA Corporation. Other trademarks referred to belong to their
respective owners.
The statements in this press release regarding DURECT’s products in development,
expected product benefits, product development plans, future clinical trials 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 research, develop, manufacture and
commercialize its products, obtain product and manufacturing approvals from
regulatory agencies, manage its growth and expenses, finance its activities and
operations, as well as marketplace acceptance of DURECT’s products. Further
information regarding these and other risks is included in DURECT’s Current
Report on Form 8-K filed with the SEC on January 11, 2002, Quarterly Report on
Form 10-Q for the quarter ended September 30, 2001 filed with the SEC on
November 13, 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.” CHRONOGESIC is under development by
DURECT and has 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, Senior Director,
Investor Relations and
Strategic Planning of DURECT Corporation,
+1-408-777-1417, or
schond.greenway@durect.com
URL: http://www.www.durect.com
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