-----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, Gzsig+QO59IkMTEyUqaD3x189fnCoD5jPjtY53u6bDcB5km82JfGl7s64ClWOpN8 FOk3GdkGjgQ+Q+87rZ2DKQ== 0001193125-05-248828.txt : 20051227 0001193125-05-248828.hdr.sgml : 20051226 20051227104141 ACCESSION NUMBER: 0001193125-05-248828 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051226 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051227 DATE AS OF CHANGE: 20051227 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: 051286267 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

 

December 26, 2005

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.)

 

10240 Bubb Road

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 December 26, 2005, DURECT Corporation, a Delaware corporation (“DURECT”), announced positive preliminary results from transdermal sufentanil patch study in patients. This Current Report is filed to disclose nonpublic information required to be disclosed by Regulation FD. 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.

 

(c) Exhibits

 

  99.1 Press Release of DURECT Corporation dated December 26, 2005


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: December 26, 2005   By:  

/s/ James E. Brown


        James E. Brown
        President and Chief Executive Officer


DURECT CORPORATION

 

INDEX TO EXHIBITS

 

Exhibit

Number


 

Description


99.1   Press Release of DURECT Corporation dated December 26, 2005
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

DURECT Announces Positive Preliminary Results from Transdermal Sufentanil Patch Study in Patients

 

Cupertino, CA-

 

December 26, 2005

 

DURECT Corporation (NASDAQ: DRRX), an emerging specialty pharmaceuticals company, announced today positive preliminary results from a multiple dose clinical study in chronic pain patients for DURECT’s TRANSDUR™-based sufentanil patch.

 

“The preliminary results of this Phase II clinical study for the TRANSDUR-Sufentanil patch indicate that the product performed as designed. The top-line preliminary results of this study showed that patients can be converted from the Duragesic® product to the TRANSDUR-Sufentanil product safely without observing clinically relevant severe adverse events. Dosing on TRANSDUR-Sufentanil was repeated for up to 4 consecutive weeks,” said James E. Brown, DURECT’s President and CEO.

 

Clinical Study Design (Phase II)

 

The clinical study was an open-label study that was designed to evaluate the transition of patients from Duragesic (commercial fentanyl patch) to the TRANSDUR-Sufentanil patch. The clinical study also evaluated the pharmacokinetics and safety of repetitive applications of the sufentanil patch in chronic pain patients for a period of up to four weeks. The clinical trial was conducted at 2 clinical sites (one in the United States and the other in Europe) and enrolled 13 adult patients in the primary study with malignant or non-malignant chronic pain.

 

Preliminary data indicate that all primary endpoints for the study were achieved, which include:

 

    Pharmacokinetic - Evaluation of plasma level data indicate that TRANSDUR-Sufentanil performed as designed by achieving its target delivery profile of providing a rapid onset of drug and a delivery duration of over 7 days. Targeted plasma levels over the consecutive 4-week period (repetitive applications of TRANSDUR-Sufentanil) were achieved as intended.

 

    Safety – The product was tolerated well with no apparent safety issues over the 4-week treatment period.

 

Preliminary Efficacy Observations:

 

    As this was an open label study, conclusions on efficacy cannot be drawn; on average, pain levels remained stable after the transition to TRANSDUR-Sufentanil.

 

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 that treat chronic debilitating diseases and enable biotechnology products. Additional information about DURECT is available at www.durect.com.

 

On March 14, 2005, DURECT granted Endo Pharmaceuticals Inc. the exclusive license to develop and commercialize the TRANSDUR-Sufentanil patch in the U.S. and Canada. This study was initiated prior to DURECT licensing this product to Endo.

 

NOTE: TRANSDUR™ is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners.


DURECT Forward-Looking Statement

 

The statements in this press release regarding DURECT’s and its collaborative partners’ products in development, anticipated product benefits, and clinical trial results and plans 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 (and that of its third-party collaborators’, where applicable) abilities to successfully enroll and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2005 filed with the SEC on October 13, 2005 under the heading “Factors that may affect future results.”

 

CONTACT: Schond L. Greenway, Executive Director, Investor Relations and Strategic Planning of DURECT Corporation, +1-408-777-1417

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