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DRRX

Started by saffeysite1, May 24, 2005, 11:34:43 PM

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setravis

Durect Hits 52-Wk High on Thursday
After Remoxy(TM) Meets Primary Endpoint
Durect Corporation (DRRX) hit a 52-week high today after its pivotal
Phase III trial for Remoxy(TM) successfully met its primary endpoint.
Remoxy, an investigational drug based on DURECT's patented
ORADUR(TM) technology, is an abuse-deterrent version of long-acting
oxycodone, a powerful painkiller available only by prescription. Remoxy
is intended to meet the needs of physicians or pharmacists who
appropriately prescribe or dispense long-acting oxycodone and who
seek to minimize the risks of abuse, misuse or diversion. ORADUR
is a sustained release oral gel-cap technology that can take the form
of an easy to swallow gelatin capsule and can provide controlled release
of active ingredients for a period of from 12 to 24 hours. ORADUR-
based products can also be manufactured by a capsule-filling
process using conventional equipment making them readily scalable.
Pain Therapeutics (PTIE) is DURECT's licensee of the rights to Remoxy,
and they in turn have sublicensed the commercialization rights
to King Pharmaceuticals (KG). DURECT Corporation is focused on the
development of pharmaceutical systems based on its proprietary drug
delivery platform technologies to treat chronic debilitating diseases and
enable biotechnology products. In addition to Oradur, these platform
technologies include the SABER(TM) Delivery System (a patented and
versatile depot injectable useful for proteins, peptides and small molecule
delivery), the TRANSDUR(TM) transdermal patch technology, the
DURIN(TM) Biodegradable Implant (drug-loaded implant system) and
the MICRODUR(TM) Biodegradable Microparticulates (microspheres
injectable system). DURECT also partners with pharmaceutical and biotechnology
companies to develop and commercialize proprietary and
enhanced pharmaceutical products based on its technologies.
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Press Release Source: DURECT Corporation


DURECT Announces Positive ELADUR(TM) Phase IIa Study Results
Tuesday December 18, 9:00 am ET


CUPERTINO, Calif., Dec. 18 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX - News) announced today positive results from a Phase IIa clinical trial for ELADUR(TM), DURECT's proprietary investigational transdermal pain patch. In this study of patients suffering from post-herpetic neuralgia, ELADUR showed improved pain control versus placebo during the 3-day continuous treatment period. In addition, ELADUR appeared well tolerated overall, and patients treated with ELADUR and placebo exhibited similar safety profiles.


(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)

"To our knowledge, this is the first topical local anesthetic formulation that supports a full 3 days of pain control from a single application," stated James E. Brown, DVM, President and CEO of DURECT. "In this study, ELADUR showed comparable safety to placebo patches as well as good wearability characteristics as patients went about their normal daily activities such as exercising and showering while wearing the patches."

This Phase IIa study was a randomized, multi-center, double-blind, placebo-controlled, two-way cross-over study of 60 patients suffering from post-herpetic neuralgia (post-shingles pain or PHN). The objectives of the study were to assess the safety as well as the magnitude, duration and characteristics of analgesic activity of ELADUR. DURECT anticipates that detailed results will be submitted for presentation at the American Pain Society Annual Meeting in May 2008.

About ELADUR

ELADUR is an investigational transdermal drug patch intended to provide up to 3 days of local pain relief from a single application, as compared to a wearing time limited to 12 hours with currently available anesthetic patches (e.g., Lidoderm®, an FDA-approved lidocaine patch for post-herpetic neuralgia pain management). Bupivacaine, the active agent in ELADUR, is a potent, FDA-approved long-acting local anesthetic used in regional anesthesia including infiltration, nerve block, epidural and intrathecal anesthesia.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies focused on treating chronic and episodic diseases and conditions. The Company currently has multiple late-stage pharmaceutical products in development initially focused on significant unmet medical needs in pain management, with a number of research programs underway in a variety of other therapeutic areas. For more information, please visit http://www.durect.com.

NOTE: ELADUR(TM) is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. ELADUR is a drug candidate under development and has not been submitted or 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 ELADUR, its anticipated attributes and commercial potential, and future presentation of results at the American Pain Society Meeting 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, DURECT's ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of ELADUR, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize ELADUR, as well as marketplace acceptance of the product candidate, and the risk that submissions to present clinical data at scientific meetings may not be accepted by the sponsoring committee meeting. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 8, 2007 under the heading "Risk Factors."
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Source: DURECT Corporation
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis