CUPERTINO, Calif., Sept. 5 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today the results of its Phase II
clinical trial for its lead product Chronogesic(TM), a 3-month continuous
infusion subcutaneous implant for the treatment of chronic pain. The clinical
trial was conducted at 9 clinical sites in the United States and enrolled 66
adult patients with chronic pain resulting from a range of causes, including
failed back surgery, trauma, arthritis, cancer pain and other chronic
diseases. Prior to the study, these patients were using a variety of approved
oral and transdermal opioid medications such as MS Contin, Oxycontin,
Duragesic and Methadone. The objective of the first portion of the study was
to determine the method by which patients can be transitioned from use of
their pre-study opioid medication to Chronogesic(TM). In the second portion
of the study, Chronogesic(TM) was implanted for up to 6 weeks to obtain
information on safety and efficacy of Chronogesic(TM) in patients with chronic
pain.
“Patients in the study reported a strong preference for Chronogesic(TM) as
measured against their pain medication used prior to the study,” stated Dennis
Fisher, MD, Vice President of Medical Affairs and Medical Director of DURECT.
“From this study, we obtained the dose conversion information required to
transition patients from commonly used opioid medications such as MS Contin,
Oxycontin, Duragesic and Methadone to Chronogesic(TM). Additionally, we
obtained very promising data that patients enrolled in the study had better
pain control and a reduction in certain opioid side effects when compared to
their pre-study medications.”
As part of the study, patients were asked to report on a variety of
factors relating to their use of Chronogesic(TM).
Global Preference
At the end of the 6-week implant period, patients were asked to compare
Chronogesic(TM) compared to their pre-study treatment. Sixty percent (60%) of
patients preferred Chronogesic(TM) to their pre-study therapy (43% of patients
“very much preferred” Chronogesic(TM) and 17% of patients “preferred”
Chronogesic(TM) whereas 35% of patients preferred their pre-study treatment
(9% of patients “very much preferred” the pre-study treatment and 26% of
patients “preferred” the pre-study treatment). Five percent (5%) of patients
indicated no preference between their pre-study treatment and Chronogesic(TM).
Pain Score Assessment
Patients were also asked about the adequacy of their pain treatment at
various points in the trial. At the beginning of the trial, prior to
receiving Chronogesic(TM), 29% of patients assessed their pre-study treatment
as “good” or “very good.” In contrast, after 6 weeks of treatment with
Chronogesic(TM), 57% of patients reported their treatment as “good” or “very
good.”
Consistent with these findings, patients reported that their mean pain
visual analog score, in which 0 is “no pain” and 10 is “worst pain
imaginable,” improved during the trial from 5.5, prior to the start of
Chronogesic(TM), to 4.8 after 6 weeks of treatment with Chronogesic(TM). Of
note, those patients who reported that Chronogesic(TM) improved their pain
status reported an improvement from a pre-study score of 5.8 to 3.8 after
6 weeks of Chronogesic(TM) treatment.
Side Effect Assessment
With respect to certain side effects commonly associated with opioids,
patients in the study reported a decrease in both gastrointestinal “pain and
discomfort” and “cramps” while using Chronogesic(TM) compared to their
pre-study treatments. Patients were also assessed daily for sleep patterns.
At the beginning of the trial, 17% of patients reported that they “never
slept” compared to the end of the 6 weeks study on Chronogesic(TM), when only
7% of patients reported that they “never slept” during one or more nights of
treatment.
“The results of the study exceeded our expectations,” stated James E.
Brown, CEO of DURECT. “Given the advantages we anticipated Chronogesic(TM)
would have over currently available therapies, such as increased patient
convenience, better compliance and physician control of dosing, we would have
been pleased with data showing that Chronogesic(TM) had equivalent pain
control compared to other opioid medicines currently on the market. However,
we saw better pain control and fewer side effects, resulting in a strong
preference by patients for Chronogesic(TM) versus other medicines. The
results of the study support our belief 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.”
Chronogesic(TM) is designed to deliver sufentanil on a continuous basis
for 3 months for the treatment of chronic pain. Sufentanil is a FDA approved
opioid that is currently used in hospitals as an anesthetic. Chronic pain is
a significant problem associated with chronic diseases, including cancer and
various neurological and skeletal disorders. Chronogesic(TM) is intended for
patients whose chronic pain is stable, opioid responsive and results from a
variety of malignant and non-malignant causes. Annual sales of opioids for
the treatment of chronic pain are in excess of $2 billion.
“We believe the results validate our product development strategy,” stated
Thomas A. Schreck, Chief Financial Officer of DURECT. “Given the strength of
our results, we are accelerating our spending on product development,
manufacturing, operations and commercialization efforts for Chronogesic(TM).
As a result of these activities, we expect to incur additional expenditures in
the third and fourth quarters of this year. We now anticipate that our third
quarter estimated net loss attributable to common stockholders will range from
$9.2 million to $9.6 million or 19 to 20 cents loss per share, and that our
fourth quarter estimated net loss attributable to common stockholders will
range from $10.0 million to $10.5 million or 21 to 22 cents loss per share.”
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. In addition to holding an exclusive license from ALZA Corporation to
develop and commercialize products in selected fields based on the DUROS(R)
implant technology, DURECT also owns multiple proprietary drug delivery
platforms including SABER(TM), a patented and versatile depot technology and
the 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.
Chronogesic(TM), SABER(TM) and IntraEAR(R) are trademarks of DURECT
Corporation. DUROS(R) is a trademark of ALZA Corporation.
The statements in this press release regarding DURECT’s clinical trials,
products in development, product development plans, expected product benefits,
potential product markets or anticipated spending and results of operations,
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, 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 Effect Future Results.”
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417,
schond.greenway@durect.com/