-----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, D13zekwDWJygrKUr4Jy7xvnEHvJuNNzn13Xb3DryXnAJ1wetw2V5DEvEFU3BybN9 pIvYbo2V3mNqkpWQTGR2UQ== 0001193125-06-090097.txt : 20060427 0001193125-06-090097.hdr.sgml : 20060427 20060427061846 ACCESSION NUMBER: 0001193125-06-090097 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060427 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060427 DATE AS OF CHANGE: 20060427 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: 06782926 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

April 27, 2006

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 April 27, 2006, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release announcing an update on its post-operative pain depot (Saber™–Bupivacaine) program. 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 April 27, 2006


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: April 27, 2006   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 April 27, 2006
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Provides An Update On Its Post-Operative Pain Depot (SABER™-Bupivacaine) Program

Cupertino, CA-

April 27, 2006

DURECT Corporation (NASDAQ: DRRX), an emerging specialty pharmaceuticals company, provided an update on its post-operative pain relief depot, SABER™-Bupivacaine program. DURECT announced results from its Phase II Australian clinical study in hernia patients and the initiation of dosing in the first U.S. clinical trial, a Phase II, placebo-controlled trial in hernia patients.

Commenting on the program, Dr. Felix Theeuwes, Chairman and Chief Scientific Officer of DURECT, said, “We are pleased with how this dosage form performs in the clinic, in particular its ease of use in the clinical setting and the controlled local delivery of bupivacaine at the surgical site, where SABER-Bupivacaine is applied. This performance is reflected in the good pharmacokinetics and safety data obtained in this first Phase II study. Based on the well known efficacy of immediate release bupivacaine, the clinical experience generated from local infusions of bupivacaine via catheter around surgical sites, and the good safety and pharmacokinetics data from this trial, we feel confident that the remainder of our Phase II program will define the optimum dosing of SABER-Bupivacaine for local post-surgical pain management.”

Phase II Australian Hernia Study

Trial Design

The Phase II trial was a dose escalation trial conducted in three cohorts, where three doses, low (Cohort 1), intermediate (Cohort 2) and high (Cohort 3), of SABER-Bupivacaine was evaluated following repair of inguinal hernia. In Cohorts 1, 2 and 3, a total of 6, 15 and 60 patients were enrolled, respectively. Cohorts 2 and 3 included control groups of 5 and 15 patients, respectively, who received commercial bupivacaine as a comparator. Prior to dose escalation, safety and an acceptable pharmacokinetic profile were established. The primary end points of the study were safety and pharmacokinetics. The study also assessed a variety of other secondary endpoints including, among others, pain intensity, pain relief and supplemental analgesic medication usage. Although the study was not designed as an efficacy study to provide statistical conclusions on such secondary endpoints, results from these evaluations are intended to guide the design of future Phase II and Phase III clinical studies.

Study Results

The results to date from the study are as follows:

All primary end-points of the study were achieved:

 

    Safety—Good safety was observed across all Cohorts, with no clinically significant drug related adverse events observed with 61 patients exposed to SABER-Bupivacaine. SABER-Bupivacaine injections also appeared to be well tolerated by patients.

 

    Pharmacokinetics—Evaluation of plasma bupivacaine concentrations showed that, across all Cohorts, SABER-Bupivacaine achieved:

 

    sustained plasma concentrations of bupivacaine as measured up to 72 hours

 

    no evidence of burst or spike in plasma concentrations of bupivacaine upon injection

 

    dose linear pharmacokinetics of bupivacaine


Secondary End-points (in Cohort 2 and Cohort 3 with comparator controls groups):

 

    In Cohort 2 (n=15), the patients who were administered SABER-Bupivacaine showed better pain relief, lower pain intensity and reduced supplemental analgesic usage compared with the patients using commercial bupivacaine as measured during the first 4 days after treatment.

 

    In Cohort 3 (n=60), no significant difference was observed in pain relief, pain intensity and supplemental analgesic usage between the patients who were administered SABER-Bupivacaine compared with the patients using commercial bupivacaine as measured during the first 4 days after treatment.

Update on Phase II Program

Dosing has been initiated in the first clinical trial in the U.S., a Phase II, placebo-controlled trial intended to enroll up to 90 patients following hernia surgery. In addition, a Phase II trial in hernia patients is on-going in the United Kingdom. During the remainder of this year, we intend to initiate several Phase II trials in the U.S. and in other countries in a variety of soft-tissue and orthopedic surgery models for the purpose of selecting the optimal dose and the pain models to be used for our pivotal trials. Pending the successful completion of these Phase II trials and approval of regulatory authorities, we will continue into Phase III trials.

About SABER-Bupivacaine

Our SABER-Bupivacaine depot under development is a sustained-release formulation of bupivacaine, an off-patent local anesthetic, using our patented SABER delivery system for the treatment of post-surgical pain. SABER-Bupivacaine is intended to be administered by the surgeon around the incision at the time of surgery. Placed in the tissues near or adjacent to the surgical site, this formulation is designed to provide sustained regional analgesia from a single dose. We believe that by delivering effective amounts of a potent anesthetic to the location from which the pain originates, adequate pain control can be achieved with minimal exposure to the remainder of the body, and hence minimal side effects. SABER-Bupivacaine is intended to provide local analgesia of 3 days or more, which we believe coincides with the time period of greatest need for post-surgical pain control in most patients. We retain the full commercialization rights to SABER-Bupivacaine.

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.

NOTE: SABER™ 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 products in development, anticipated product benefits and clinical trial results and future clinical trial 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 ability to successfully design, enroll, conduct 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 Annual Report on Form 10-K filed with the SEC on March 16, 2006 under the heading “Risk Factors.”

CONTACT: Schond L. Greenway, Vice President, Investor Relations and

Strategic Planning of DURECT Corporation, +1-408-777-1417

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