CUPERTINO, Calif., Apr 2, 2002 /PRNewswire-FirstCall via COMTEX/ — DURECT
Corporation (Nasdaq: DRRX) announced today that it has filed an Investigational
New Drug application to investigate the delivery of cromolyn sodium for the
treatment of asthma. This IND was filed as part of an ongoing program to develop
a product for the treatment of asthma and allergic rhinitis (seasonal allergies)
utilizing one of the Company’s proprietary biodegradable drug delivery
platforms. Cromolyn sodium, a non-steroidal anti-allergy medication, is an
FDA-approved drug for the management of mild-to-moderate persistent asthma and
is recommended for early intervention and daily anti-inflammatory therapy.
Cromolyn sodium has an excellent safety profile, and its position in asthma
therapy is well-established.
Asthma is a serious, chronic, potentially life-threatening condition that
affects approximately 15-17 million people in the U.S. Allergic rhinitis is the
fifth most common chronic disease in the U.S., and affects as many as 40 million
people in the U.S. Sales of asthma and allergic rhinitis treatments exceeded $5
billion in 2000.
Dr. Stephen Tilles, Executive Director of ASTHMA, Inc., Seattle, Washington, is
the lead investigator for the initial trial. Dr. Tilles notes that, “cromolyn, a
non-steroidal anti-allergy medication, has demonstrated itself to be one of the
safest agents to control the onset of mild-to-moderate bronchospasm in asthma
patients, without the detrimental side effects of commonly-used steroids.
Cromolyn’s traditional means of administration by inhalation causes difficulties
with patient compliance, resulting in sub-optimal therapy and limited utility in
asthma and seasonal allergies. DURECT’s unique controlled-release drug delivery
technology may provide the benefits of cromolyn to a much broader population of
patients, particularly if it proves to be steroid-sparing. With optimal dosing,
cromolyn may prove to be one of the most effective agents for the treatment of
persistent asthma. Our staff looks forward to working with DURECT on this
initial clinical trial.”
Overall Study Design and Plan
The Phase I study will be a single-center study that will enroll patients with
exercise-induced bronchospasm. Patients will be evaluated for five weeks.
Efficacy will be assessed by evaluating pulmonary function and plasma
concentrations of cromolyn sodium following an exercise challenge. Safety will
be assessed by evaluating clinical laboratory tests, significant adverse events,
physical examination and vital signs.
“Asthma and allergy are rapidly growing markets that are in need of a safe and
effective therapeutic alternative with a longer duration of therapy,” stated Jim
Brown, CEO of DURECT. “The development of a biodegradable drug delivery product
may have a significant impact on patient compliance, and we hope will expand the
current therapeutic options for patient care.”
DURECT Corporation (www.www.durect.com) 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 lead product in development, the CHRONOGESIC(TM)
(sufentanil) Pain Therapy System, a 3-month product for the treatment of chronic
pain, completed a pilot phase III study in December 2001. DURECT 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).
NOTE: CHRONOGESIC(TM) is a trademark of DURECT Corporation. SABER(TM),
MICRODUR(TM) and DURIN(TM) are trademarks of Southern BioSystems, Inc., a wholly
owned subsidiary of DURECT Corporation.
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 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 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 Annual
Report on Form 10-K for the fiscal year ended December 31, 2001 filed with the
SEC on March 28, 2002, under the heading “Factors that may affect future
results,” and other periodic reports filed with the SEC. 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.
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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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