CUPERTINO, Calif.,
(Nasdaq: DRRX) today reported that
received a Complete Response Letter from the
(FDA) for its New Drug Application (NDA) for REMOXY(R), an abuse-resistant
controlled-release form of oxycodone. Based on its review, the FDA has
determined that the NDA is not approved in its present form.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)
According to
commercial partner for REMOXY, the FDA believes additional non-clinical data
will be required to support the approval of REMOXY. The FDA has not requested
or recommended additional clinical efficacy studies prior to approval.
Therapeutics
are evaluating the FDA Complete Response Letter, will discuss the Letter with
the FDA, and will provide an update when appropriate.
to develop and commercialize REMOXY and other abuse-resistant pain
medications.
REMOXY is being developed by
and
for this drug candidate to
ORADUR(TM) technology, is an investigational drug that is a unique,
abuse-resistant, controlled release formulation of oxycodone for
moderate-to-severe chronic pain.
About ORADUR(
ORADUR is a proprietary technology designed to transform short-acting oral
capsule dosage forms into sustained release oral products, with the added
benefit of being less prone to abuse (e.g. by crushing or water extraction)
than other controlled release dosage forms on the market today.
Corporate Relationships
In
develop and commercialize on a worldwide basis REMOXY and other oral sustained
release drug candidates using the ORADUR technology which incorporate four
specified opioid compounds. Under the license agreement,
for formulation and other work performed under its agreement with
Therapeutics
regulatory milestones are achieved with respect to the licensed drug
candidates. In addition, if commercialized,
REMOXY and the other licensed drug candidates of between 6.0% to 11.5% of net
sales of the drug candidate depending on sales volume as well as a mark-up on
candidates.
REMOXY and other licensed drug candidates to
2005
About
innovative drugs for pain and other chronic diseases, with late-stage
development programs including REMOXY(R), POSIDUR(TM), ELADUR(TM), and
TRANSDUR(TM)-Sufentanil.
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 http://www.www.durect.com.
NOTE: POSIDUR(TM), SABER(TM), ORADUR(TM), TRANSDUR(TM), and ELADUR(TM) are
trademarks of
respective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug
candidates under development and have not been approved for commercialization
by the
DURECT Forward-Looking Statement
The statements in this press release regarding REMOXY its potential
attributes and statements related to plans by
Pharmaceuticals
provide an update when appropriate 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 potential that FDA may not
grant regulatory approval of REMOXY, difficulties or delays in the
development, testing, regulatory approval, production and commercialization of
REMOXY, and unexpected adverse side-effects or inadequate therapeutic efficacy
of REMOXY that could slow or prevent product approval or market acceptance
(including the risk that current and past results of clinical trials are not
necessarily indicative of future results of clinical trials). Further
information regarding these and other risks is included in
dated
SOURCE
CONTACT:
Corporation
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Web site: http://www.www.durect.com