DURECT Corporation
(Nasdaq: DRRX) today announced that we have started Phase II dosing in the
U.S. under an FDA-accepted Investigational New Drug (IND) application for
TRANSDUR(TM)-Bupivacaine (DUR-843), a transdermal pain patch for patients
suffering from Post-Herpetic Neuralgia (post-shingles pain or PHN).
DURECT's Phase I trial for TRANSDUR-Bupivacaine, initially reported on
December 11, 2006, demonstrated good safety, tolerability and drug release
for up to 3 days. TRANSDUR-Bupivacaine is intended to provide up to 3 days
of pain relief for patients suffering from PHN, as compared to a wearing
time limited to 12 hours with currently available patches.
"The initiation of the Phase II program for TRANSDUR-Bupivacaine is an
important milestone for us," said James E. Brown, DURECT's President and
CEO. "Based on our TRANSDUR technology, we believe that the product profile
of TRANSDUR-Bupivacaine represents an improvement over existing pain
control products for patients suffering from PHN."
DURECT's Phase II program for TRANSDUR-Bupivacaine has begun with a
randomized, multi-center, double-blind, placebo controlled, two-way
crossover trial in approximately 50 patients with PHN to assess safety as
well as the magnitude, duration and characteristics of analgesic activity
of TRANSDUR- Bupivacaine.
Bupivacaine, the active agent in TRANSDUR-Bupivacaine, is a potent,
FDA- approved long-acting local anesthetic used in regional anesthesia
including infiltration, nerve block, epidural and intrathecal anesthesia.
Bupivacaine is a more potent sodium channel blocker and has a longer
duration of action than lidocaine, the active ingredient for Lidoderm(R),
the market leader for post- herpetic neuralgia pain management.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company
focused on the development of pharmaceutical systems based on its
proprietary drug delivery platform technologies focused on treating chronic
and episodic diseases and conditions. The Company currently has a number of
late-stage pharmaceutical products in development initially focused on
significant unmet medical needs in pain management, with a number of
research programs underway in a variety of other therapeutic areas. For
more information, please visit durect/.
TRANSDUR(TM) is a trademark of DURECT Corporation. TRANSDUR-
Bupivacaine is a drug candidate under development and has not been
submitted or approved for commercialization by the US Food and Drug
Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT's products in
development including TRANSDUR-Bupivacaine and product development plans
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 (and that of its third party collaborators
where applicable) abilities to design, enroll, conduct and complete
clinical trials, complete the design, development, and manufacturing
process development of the product candidate, obtain product and
manufacturing approvals from regulatory agencies and manufacture and
commercialize the product candidate, as well as marketplace acceptance of
the product candidate. Further information regarding these and other risks
is included in DURECT's Form 10-Q dated November 3, 2006 under the heading
"Risk Factors."
DURECT Corporation
durect/
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