-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, CEFdQ06yqzyYWcxCMDoSdJ2c/X7yjlm4kJD0ZuZ8LSAI8Dxki1Cf7SUPakUcZEL7 uKJXXr9ZKXPJBYVnpmhhIQ== 0001193125-07-153943.txt : 20070712 0001193125-07-153943.hdr.sgml : 20070712 20070712124710 ACCESSION NUMBER: 0001193125-07-153943 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070711 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070712 DATE AS OF CHANGE: 20070712 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DURECT CORP CENTRAL INDEX KEY: 0001082038 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943297098 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31615 FILM NUMBER: 07975901 BUSINESS ADDRESS: STREET 1: 10240 BUBB RD CITY: CUPERTINO STATE: CA ZIP: 95014 BUSINESS PHONE: 4087771417 MAIL ADDRESS: STREET 1: 10240 BUBB ROAD CITY: CUPERTINO STATE: CA ZIP: 95014 8-K 1 d8k.htm FORM 8-K Form 8-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


Form 8-K

 


Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

July 11, 2007

Date of Report

(Date of earliest event reported)

 


DURECT CORPORATION

(Exact name of Registrant as specified in its charter)

 


 

Delaware   000-31615   94-3297098

(State or other jurisdiction of

incorporation or organization)

  (Commission File Number)  

(I.R.S. Employer

Identification No.)

2 Results Way

Cupertino, CA 95014

(Address of principal executive offices) (Zip code)

(408) 777-1417

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



Item 8.01 Other Events

On July 11, 2007, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release announcing that patient recruitment has been completed in the pivotal Phase III study with Remoxy, an abuse resistant pain medicine under development based on DURECT’s patented ORADUR technology incorporating the opioid oxycodone. A copy of DURECT’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits

(d) Exhibits

 

        99.1   Press Release of DURECT Corporation dated July 11, 2007


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  DURECT Corporation
Date: July 11, 2007   By:  

/s/ James E. Brown

    James E. Brown
    President and Chief Executive Officer


INDEX TO EXHIBITS

 

Exhibit
Number

  

Description

99.1

   Press Release of DURECT Corporation dated July 11, 2007
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

Patient Recruitment Completed for Pivotal Phase III Study of Remoxy™

CUPERTINO, CA, July 11, 2007 /PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) today reported that patient recruitment has been completed in the pivotal Phase III study with Remoxy, an abuse resistant pain medicine under development based on DURECT’s patented ORADUR technology incorporating the opioid oxycodone. This event was announced today by Pain Therapeutics, Inc. (Nasdaq: PTIE) and King Pharmaceuticals (Nasdaq: KG); Pain Therapeutics is DURECT’s licensee of the rights to this drug candidate and they in turn have sublicensed the commercialization rights to King Pharmaceuticals.

This randomized, double-blinded, placebo-controlled study enrolled patients in the U.S. with moderate-to-severe osteoarthritic pain. Following a titration period, patients were randomized to either twice-daily Remoxy (10-80 mg daily) or placebo for 12 weeks. The primary endpoint is change in pain scores during the treatment period. According to Pain Therapeutics and King Pharmaceuticals, this Remoxy study is being conducted under the auspices of a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and top line results of this study are expected in the fourth quarter of 2007, after the last patient completes the three-month treatment period.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company developing pharmaceutical systems based on its proprietary drug delivery platform technologies. The Company currently has a number of late-stage pharmaceutical products in development addressing large markets in pain management, with a number of research programs underway targeting chronic disease and other therapeutic areas. For more information, please visit www.durect.com.

NOTE: ORADUR™ is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. Remoxy is 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 Remoxy, its potential attributes and expected clinical trials results 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, Pain Therapeutics and King Pharmaceutical’s abilities to design, conduct and complete clinical trials, obtain successful results from such clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain regulatory and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT’s Form 10-Q dated May 9, 2007 under the heading “Risk Factors.”

SOURCE:

DURECT Corporation

CONTACT:

Matthew J. Hogan, Chief Financial Officer of DURECT Corporation, +1-408-777-4936, mhogan@durect.com

Media Contact:

Feinstein Kean Healthcare

Jeremiah Hall, Senior Vice President, +415 677-2700, jeremiah.hall@fkhealth.com

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