CUPERTINO, Calif., Jan. 27, 2011 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today reported that the U.S. Food and Drug
Administration (FDA) has accepted the resubmission of the New Drug
Application (NDA) for REMOXY® by King Pharmaceuticals, Inc. (NYSE:
KG) and the PDUFA goal date is June 23,
2011.
(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)
REMOXY, based on DURECT's ORADUR® 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.
Approximately 50 million Americans suffer from persistent
pain each year, according to the American Pain Foundation.
About ORADUR® 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 resisting common methods of
prescription drug misuse and abuse compared to other controlled
release dosage forms on the market today.
Corporate Relationships
In December 2002, DURECT licensed
to Pain Therapeutics, Inc. (Nasdaq: PTIE) 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
Therapeutics sublicensed the commercialization rights of REMOXY and
other licensed drug candidates to King Pharmaceuticals in
November 2005. In October 2010, Pfizer Inc. (NYSE: PFE) announced
that it had entered into a definitive merger agreement to acquire
King. Should that transaction be completed, Pfizer would
assume the development and commercialization rights and obligations
to REMOXY and to the other licensed ORADUR-based opioids.
About DURECT Corporation
DURECT is a specialty pharmaceutical company developing
innovative drugs for pain and other chronic diseases, with
late-stage development programs including REMOXY®, POSIDUR™,
ELADUR™, and TRANSDUR™-Sufentanil. DURECT's proprietary oral,
transdermal and injectable depot delivery technologies may 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.durect.com.
NOTE: POSIDUR™, SABER™, ORADUR®, TRANSDUR™, and ELADUR™ 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 U.S. 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 the expected PDUFA
review date goal by the FDA, the potential of FDA approving the
REMOXY NDA, the potential royalty and other payments that may be
received by DURECT from REMOXY and other described products, and
the potential acquisition of King by Pfizer 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, and that the Pfizer
acquisition of King may not be completed. Further information
regarding these and other risks is included in DURECT's Form 10-Q
dated November 4, 2010 under the
heading "Risk Factors."
SOURCE DURECT Corporation