CUPERTINO, Calif., June 25 /PRNewswire/ —
DURECT Corporation (Nasdaq: DRRX) announced today that it has filed a Special
510(k) pre-market notification with the FDA for its next generation ear
delivery catheter. Like its predecessor IntraEAR(R) catheters, the Microdose
Cath(TM) is intended for the site-directed delivery of fluids to the round
window area of the middle ear for the treatment of ear disorders.
Additionally, DURECT announced that the Naval Medical Center San Diego
(“NMCSD”) will be evaluating the IntraEAR(R) Microdose Cath(TM) as part of an
FDA accepted physician-sponsored Investigational New Drug (“PIND”) study.
NMCSD will use the catheter as part of a blinded, non-active controlled study
evaluating the use of gentamicin for the treatment of Meniere’s disease. Due
to the nature of the progression of Meniere’s disease, the clinical evaluation
period for this study may last up to two years.
Inner ear disorders, including tinnitus, hearing loss and Meniere’s
disease impact the lives of millions of people worldwide. Meniere’s disease,
which affects three to five million Americans, is a combination of vertigo,
progressive fluctuating hearing loss, tinnitus and a sensation of pressure in
the ear. Approximately 100,000 new cases are diagnosed each year in the US,
30,000 of whom continue to suffer after medical and dietary treatments fail.
“NMCSD has been a pioneer in the development of novel therapies for the
many patients suffering from inner ear disorders such as Meniere’s disease,”
said Tim Nelson, Vice President of Commercial and Business Development for
DURECT. “In comparison to the patient outcomes of bolus injection of
gentamicin, we believe the site directed treatment being studied by the NMCSD
may help to minimize hearing loss while also better preserving balance
function in Meniere’s disease patients. DURECT is pleased that the NMCSD has
taken the initiative to further evaluate this very promising therapy under a
blinded, non-active controlled study.”
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.
DURECT’s lead product in development 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. DUROS
sufentanil 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 exceed $1 billion.
DURECT’s second product in development continuously delivers hydromorphone to
the spine. DURECT also sells FDA cleared catheters for the delivery of fluids
to the inner ear and manufactures and sells and distributes the ALZET(R)
osmotic pump product for use in laboratory research.
Southern BioSystems, Inc., a wholly owned subsidiary of DURECT
Corporation, researches, develops and manufactures controlled-release drug
delivery products to help clients commercialize human and veterinary
pharmaceuticals. Southern BioSystems has three drug-delivery platforms: the
proprietary SABER(TM) delivery system, microspheres and drug-loaded implants.
SABER(TM) is a biodegradable highly viscous liquid that can be formulated for
oral, parenteral dermal or other routes of administration. Southern BioSystems
has the capabilities to formulate microspheres for oral, parenteral, dermal or
other routes of administration. Southern BioSystems also develops drug-loaded
implants and, through its subsidiary Birmingham Polymers, also manufactures
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. 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.
DUROS is a registered trademark of ALZA Corporation. IntraEAR 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 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 April 30, 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.
For further information please contact:
DURECT Corporation
Schond L. Greenway
Director, Investor Relations
Phone: (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/