CUPERTINO, Calif., June 10 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today that a New Drug Application (NDA) for
Remoxy(TM) (ORADUR(TM)-based oxycodone) has been submitted to the U.S. Food
and Drug Administration (FDA). Remoxy, an investigational drug, is a long
acting oral formulation of oxycodone intended to treat moderate to severe
pain. Based on DURECT’s ORADUR technology, Remoxy is designed to resist
common methods of prescription drug misuse and abuse.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)
“We are pleased that the first NDA has been filed for a drug candidate
using one of DURECT’s platform technologies,” stated James E. Brown, DVM,
President and CEO of DURECT. “The abuse of pain medications is a widespread
problem in this country and addressing that issue is clearly in the public
interest. We designed our ORADUR technology to enable the abuse resistant
properties of drug candidates such as Remoxy which has the potential to be the
first oxycodone on the market that deters common methods of abuse.”
Remoxy is being developed by Pain Therapeutics under license from DURECT,
and Pain Therapeutics has, in turn, sublicensed the commercialization rights
to the drug candidate to King Pharmaceuticals. King and Pain Therapeutics
have stated that they believe the NDA for Remoxy benefits from years of
rigorous and independent scientific and clinical testing, and the NDA includes
animal and human data from extractability, pharmacokinetic, toxicology and
clinical studies.
About the NDA for Remoxy (as announced by King and Pain Therapeutics)
Pain Therapeutics submitted the NDA in accordance with the FDA’s
Electronic Common Technical Document specifications. Pursuant to Prescription
Drug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whether
to accept the NDA for filing within 90 days. At that time Pain Therapeutics
will also learn if the NDA filing was granted priority review. A Priority
Review designation is given to drugs that offer real advances in treatment, or
provide a treatment where no adequate therapy exists. A Priority Review means
that the time it takes FDA to review a NDA is reduced from 12 months to
approximately 6 months.
About the Development Program for Remoxy (as announced by King and Pain
Therapeutics)
The development program for Remoxy consisted of several clinical studies,
including one pivotal Phase III study conducted under a Special Protocol
Assessment (SPA), which evaluated the safety and efficacy of Remoxy in over
400 patients with osteoarthritis. With a SPA, the study design, endpoints and
statistical analyses needed to support approval were agreed upon by the FDA
prior to initiating the study and are considered binding. Pain Therapeutics
and King have stated that they believe that the SPA for Remoxy remains in
full-force without modification. The following summarizes the pivotal Phase
III results:
— Pursuant to the SPA, the primary endpoint of the Remoxy pivotal Phase
III study was defined as mean decrease in pain intensity scores between
Remoxy and placebo during the 12-week treatment period.
— The study achieved a statistically significant result in its primary
endpoint (p less than 0.01).
— In addition, the study achieved statistically significant results in
secondary endpoints such as Quality of Analgesia (p less than 0.01) and
Global Assessment (p less than 0.01).
About Oxycodone Abuse
Please visit the U.S. Drug Enforcement Administration’s website for more
information:
http://www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycodone.htm
About Chronic Pain
Approximately 50 million Americans suffer with chronic pain, a distinct
type of pain, often with no cure. It can affect an individual throughout his
or her life, lasting several weeks, months, or even years at a time. The
onset of chronic pain may be nociceptive (caused by ongoing tissue injury),
neuropathic (caused by damage to the brain, spinal cord, or peripheral
nerves), or disease specific (such as osteoarthritis or cancer).
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 with Pain
Therapeutics, 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 certain 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
to Remoxy and other licensed drug candidates to King Pharmaceuticals in
November 2005.
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 than other controlled release dosage
forms on the market today.
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, 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 http://www.www.durect.com.
NOTE: ORADUR(TM), POSIDUR(TM), ELADUR(TM) and TRANSDUR(TM) are trademarks
of DURECT Corporation. Other referenced trademarks belong to their respective
owners. Remoxy(TM) is a drug candidate under development and has 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 attributes and
its potential to be the first oxycodone on the market that deters common
methods of abuse, the potential acceptance of the Remoxy NDA filing and
granting of priority review by the FDA, the potential benefits of scientific
and clinical testing data included in the Remoxy NDA and the potential
milestone, royalties and other payments to DURECT from the development and
commercialization of Remoxy 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, difficulties or delays in the development, testing,
regulatory approval, production and commercialization of Remoxy, unexpected
delays in the acceptance or review of NDA filing for Remoxy by the FDA, 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 DURECT’s Form 10-Q dated May 8,
2008 under the heading “Risk Factors.”
SOURCE DURECT Corporation
06/10/2008
CONTACT: Matt Hogan, Chief Financial Officer of DURECT Corporation,
+1-408-777-4936
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Web site: http://www.www.durect.com