DURECT Announces Filing of Special 510(k) Application for its New Generation IntraEAR(R) Ear Catheter Product and Approval of Physician Sponsored Investigational New Drug Application for Treatment of Meniere’s Disease

Download PDF:

CUPERTINO, Calif., Jun 25, 2001 /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

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

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

                    MAKE YOUR OPINION COUNT -  Click Here


CONTACT:          Schond L. Greenway Director, Investor Relations of DURECT
                  Corporation, 408-777-1417, schond.greenway@durect.com
Scroll to Top