DURECT Corporation
(Nasdaq: DRRX) announced that the US Food and Drug Administration
(FDA) has granted to DURECT orphan drug designation for bupivacaine for
relief of persistent pain associated with post-herpetic neuralgia (PHN).
Bupivacaine is the active pharmaceutical ingredient in ELADUR(TM), DURECT's
investigational transdermal drug patch. If ELADUR is the first bupivacaine
product approved for PHN, under the 1983 Orphan Drug Act ELADUR will
receive seven years of market exclusivity following the approval of the
product by the FDA.
"The receipt of orphan drug status enhances the product opportunity for
ELADUR, including providing a more favorable development pathway," stated
James E. Brown, DVM, President and CEO of DURECT. "We are continuing to
develop ELADUR as a potentially best in class transdermal product for those
suffering from PHN."
ELADUR is an investigational transdermal drug patch intended to deliver
bupivacaine for up to 3 days from a single application, as compared to a
wearing time limited to 12 hours with currently available anesthetic
patches (e.g., Lidoderm(R), an FDA-approved lidocaine patch for
post-herpetic neuralgia pain management). Bupivacaine, the active agent in
ELADUR, is a potent, FDA-approved long-acting local anesthetic used in
regional anesthesia for local tissue infiltration, nerve block, and
epidural and intrathecal anesthesia. DURECT currently retains full
commercial rights to this product candidate.
DURECT has previously announced positive results for ELADUR from a 60
patient Phase IIa clinical trial of patients suffering from post-herpetic
neuralgia. In this study, ELADUR showed improved pain control versus
placebo during the 3-day continuous treatment period. In addition, ELADUR
appeared to be well tolerated overall, and patients treated with ELADUR and
placebo exhibited similar safety profiles. A poster describing this study
was presented at the 27th Annual Scientific Meeting of the American Pain
Society on May 8, 2008 and is accessible on our website
(durect/wt/durect/page_name/Publications).
About DURECT Corporation
DURECT is an emerging specialty pharmaceutical company developing
innovative drugs for pain and other chronic diseases, with late-stage
development programs including Remoxy(TM), POSIDUR(TM), ELADUR(TM), and
TRANSDUR(TM)-Sufentanil. DURECT's proprietary oral, transdermal and
injectable depot delivery technologies enable new indications and superior
clinical/commercial attributes such as abuse deterrence, improved
convenience, compliance, efficacy and safety for small molecule and
biologic drugs. For more information, please visit durect.
ORADUR(TM), POSIDUR(TM), ELADUR(TM) and TRANSDUR(TM) are
trademarks of DURECT Corporation. Other referenced trademarks belong to
their respective owners. Remoxy, POSIDUR, ELADUR and TRANSDUR-Sufentanil
are drug candidates under development and have not been 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 ELADUR, its anticipated
attributes and commercial potential, its potential to be a best in class
transdermal product for those suffering from PHN and its potential to
receive seven years of market exclusivity as an orphan drug 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, the risk that ELADUR may not be the first bupivacaine product approved
for PHN, DURECT's ability to design, enroll, conduct and complete clinical
trials, complete the design, development, and manufacturing process
development of ELADUR, obtain product and manufacturing approvals from
regulatory agencies and manufacture and commercialize ELADUR, 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 May
8, 2008 under the heading "Risk Factors."
DURECT Corporation
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