DURECT Corporation Announces Fourth Quarter and Year End 2007 Financi...(mprovements in paincontrol while reducin...)

Date:2/5/2008

mprovements in pain control while reducing the use of narcotics in a Phase IIb hernia study, and ELADUR(TM) showed improved pain control versus placebo over the three day treatment period in a Phase IIa study. Each of these programs addresses large market opportunities with product features that offer clear advantages over existing therapeutics."
Highlights for DURECT in Fiscal Year 2007 include:

-- Remoxy. In December, our collaborators King Pharmaceuticals and Pain

Therapeutics announced that the pivotal Phase III trial for Remoxy

successfully met its primary endpoint (p<0.01) that was prospectively

defined by the U.S. Food and Drug Administration (FDA) during the SPA

process. In addition, the study achieved statistically significant

results in secondary endpoints such as Quality of Analgesia (p<0.01)

and Global Assessment (p<0.01). No drug related safety issues were

noted in the study.

Remoxy is an abuse-resistant, long-acting form of oxycodone based on

our ORADUR(TM) technology intended for the treatment of chronic pain.

-- POSIDUR Post-Operative Pain Relief Depot. In July, we announced

positive results from a 122 patient Phase IIb clinical trial in which

POSIDUR at a dose of 5 mL demonstrated statistically significant

reductions in post-operative pain (by approximately 30% versus placebo)

and in total consumption of supplemental opioid analgesic medications

(approximately 3x less versus placebo) in patients undergoing inguinal

hernia repair. These successful results triggered an $8 million

milestone payment by Nycomed to DURECT under the parties' international

collaborative agreement. We have held an end-of-Phase II meeting with

the U.S. Food & Drug Administration (FDA) and are in dialogue with the

FDA regarding the Phase III program. Hospira, our manufacturer o
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SOURCE DURECT Corporation Copyright©2008 PR Newswire. All rights reserved

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