(Nasdaq: DRRX) today reported that
Response Letter regarding the New Drug Application (NDA) for REMOXY(R).
meeting last week provided King with a clear path forward to resubmit the
REMOXY NDA and to address all FDA comments in the Complete Response Letter.
According to the
King now anticipates the resubmission of the NDA could occur mid-year 2010.
King believes that the rate limiting step is the generation of six-month
stability data, and no new clinical trials are required. King has stated that
it remains committed to the development and commercialization of REMOXY and
looks forward to working closely with the FDA toward approval of the product.
REMOXY, based on
drug that is a unique, controlled release formulation of oxycodone for
moderate-to-severe chronic pain designed to reduce potential risks of
unintended use. In mid-2008, an NDA for REMOXY was accepted by the FDA and
was granted Priority Review. In
Complete Response Letter from the FDA. Subsequent to the receipt of the
Complete Response Letter, King assumed full control of all activities related
to the development of REMOXY.
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 alcohol or water
extraction) than other controlled release dosage forms on the market today.
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, and will receive
additional payments if certain development and regulatory milestones are
achieved with respect to the licensed drug candidates. In addition, if
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
key excipients used in the manufacture of the licensed drug candidates.
licensed drug candidates to
innovative drugs for pain and other chronic diseases, with late-stage
development programs including REMOXY(R), POSIDUR(TM), ELADUR(TM), 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 www.www.durect.com.
NOTE: POSIDUR(TM), SABER(TM), ORADUR(TM), TRANSDUR(TM), and ELADUR(TM) are
respective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug
candidates under development and have not been approved for commercialization
DURECT Forward-Looking Statement
The statements in this press release regarding REMOXY its potential
attributes and statements related to plans by
timing of such resubmission, the generation of stability data as described
above, the potential of FDA approving the REMOXY NDA, the timing and content
of any potential update to be provided by
as the potential royalty and other payments that may be received by
from REMOXY and other described products 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 the REMOXY
NDA resubmission may not adequately address all of FDA’s concerns, 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 and tests are not necessarily indicative of future results of
clinical trials and tests). Further information regarding these and other
risks is included in
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Web Site: http://www.www.durect.com