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CUPERTINO, Calif., July 7 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) today reported that King Pharmaceuticals, Inc. (NYSE: KG) and
Pain Therapeutics, Inc. (Nasdaq: PTIE) have announced that King met with the
Food and Drug Administration (FDA) on July 2, 2009 to discuss the Complete
Response Letter regarding the New Drug Application (NDA) for REMOXY(R).
According to King Pharmaceuticals and Pain Therapeutics, the outcome of the
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 Pharmaceuticals / Pain Therapeutics press release,
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 DURECT’s ORADUR(TM) technology, is an investigational
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 December 2008, Pain Therapeutics received a
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.

About ORADUR(TM) Technology

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.

Corporate Relationships

In December 2002, DURECT licensed to Pain Therapeutics, Inc. the right to
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, DURECT is reimbursed
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
commercialized, DURECT will receive royalties for 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 DURECT’s supply of
key excipients used in the manufacture of the licensed drug candidates. Pain
sublicensed the commercialization rights of REMOXY and other
licensed drug candidates to King Pharmaceuticals in November 2005.

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(R), 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

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 REMOXY its potential
attributes and statements related to plans by Pain Therapeutics and King
for resubmission of the REMOXY NDA, including the contents and
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 Pain Therapeutics and King, as well
as the potential royalty and other payments that may be received by DURECT
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 DURECT’s Form 10-Q dated May 7, 2009 under the heading
“Risk Factors.”


CONTACT: Matthew J. Hogan, Chief Financial Officer, DURECT Corporation,
PRN Photo Desk, +1-888-776-6555 or +1-212-782-2840
Web Site:

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