Navigation Links
DURECT Reports Positive Phase IIb Data from TRANSDU(TM)-Sufentanil Clinical Program
Date:3/16/2009

udy, approximately half (36 out of 74) of the screened patients successfully entered the maintenance period, which is consistent with expectations for the study and with other chronic pain studies of a similar nature. After exploring multiple dose titration regimens, two acceptable dose titration intervals have achieved the desired analgesic effect and side-effect profile, and therefore are expected to be utilized in Phase III.

Relative Potency

As a result of converting screened patients to stable pain control and into the maintenance period (see above), the conversion ratios from oral morphine equivalents at baseline to TRANSDUR-Sufentanil dosage strengths were established and are expected to be utilized in the Phase III program.

Efficacy

Although not the main goal of the study, the mean pain score during the maintenance period of 3.88 (on a numerical ratings scale for pain intensity of 0-10, with 0 being no pain) represented a reduction of approximately 19% from the mean baseline pain score of 4.78. These pain scores represent the mean for the patients that had a maintenance pain value and a baseline pain value (n=36) and computations were based on the intention-to-treat patients set. Only 1 patient out of 36 (approximately 2.8%) dropped out of the study during the maintenance period for lack of efficacy.

Safety and Tolerability

The safety summary is consistent with commonly expected adverse events using transdermal therapy systems with opioids. Only 1 out of 74 patients (approximately 1.4%) dropped out of the study due to application site reaction (local pruritis) and that one instance occurred during the first visit. No patients dropped out of the study due to application site adverse events during the maintenance period. No patients' adverse events were rated as severe.

About TRAN
'/>"/>

SOURCE DURECT Corporation
Copyright©2009 PR Newswire.
All rights reserved

1

GOOD

Page: 1 2 3 4 5

Related medicine technology :

1. DURECT Announces Positive ELADUR(TM) Phase IIa Study Results
2. ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia
3. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
4. Spherix Reports Second Quarter Earnings
5. Tapestry Reports Second Quarter 2007 Results
6. Callisto Reports on Second-Quarter 2007 Milestones
7. ImmuneRegen BioSciences Reports Material Transfer Agreement with VaxGen, Inc.
8. Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs
9. Paper in International Journal of Oncology Reports Alfacells ONCONASE(R) Suppresses Intracellular Oxidative Stress
10. TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS(R) Drug-eluting Stent in Women
11. Biopure Reports on Meeting with the FDA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/18/2013)... 2013   Polymer Technology Systems, Inc. ... Group to integrate the CardioChek ® ... by health systems across the country. The CardioChek ... distributed through Hanson Medical Systems , offers ... LDL cholesterol, triglycerides, and glucose. (Logo: ...
(Date:6/17/2013)... , June 17, 2013 DNAtrix Inc., experts ... will present clinical data on the company,s lead product, ... Quebec City, Canada on June ... DNAtrix,s CEO and a leader in the field of ... study entitled A PHASE I TRIAL OF A CONDITIONALLY ...
(Date:6/17/2013)... The following is a Statement of Steve Pasierb , ... Last Friday, Urban Outfitters issued a ... prescription drug paraphernalia products. The statement read, "In this extensive ... there may be individual items that are misinterpreted by people ... misinterpretation we are electing to discontinue these few styles from ...
Breaking Medicine Technology:Polymer Technology Systems, Inc. to Provide Point-of-Care Lipid Testing to Aegis Health Group's Hospital Clients 2Polymer Technology Systems, Inc. to Provide Point-of-Care Lipid Testing to Aegis Health Group's Hospital Clients 3DNAtrix, Inc. to Present Clinical Study Results for DNX-2401 (Delta 24-RGD), A Conditionally Replication-Competent Adenovirus 2A Win for Families: Urban Outfitters Halts Prescription Drug Paraphernalia Product Sales 2
... HealthWarehouse.com, Inc. (ticker: HEWA) a leading VIPPS-accredited, ... President and CEO, will present at RetailInvestorConferences.com. Company ... virtual conference.DATE: , May 5, 2011TIME: ... the red "register/ watch event now" button.This will ...
... OMCL ), a leading global provider of system ... first quarter ended March 31, 2011. GAAP results: ... million as compared with $57.3 million for the fourth quarter ... first quarter 2010 revenue of $54.2 million. Net ...
Cached Medicine Technology:HealthWarehouse.com, Inc. to Present Live at RetailInvestorConferences.com on May 5th 2Omnicell Announces First Quarter 2011 Results 2Omnicell Announces First Quarter 2011 Results 3Omnicell Announces First Quarter 2011 Results 4Omnicell Announces First Quarter 2011 Results 5Omnicell Announces First Quarter 2011 Results 6Omnicell Announces First Quarter 2011 Results 7Omnicell Announces First Quarter 2011 Results 8Omnicell Announces First Quarter 2011 Results 9Omnicell Announces First Quarter 2011 Results 10
(Date:6/18/2013)... (PRWEB) June 18, 2013 Sun Buick GMC, ... Family Health Services 20th Annual Golf Tournament on Thursday, June ... The hole-in-one prize is a 2013 Buick Verano and will ... gets a hole-in-one on Irem’s 7th hole. , The MFHS ... format is a four person captain and crew team for ...
(Date:6/18/2013)... have a much different and more complex ... of Texas at Dallas have found that exploiting these ... cancer. , In an article published online May 21 ... researchers compared the metabolic characteristics of non-small-cell lung cancer ... patient. , They found that the cancer cells ...
(Date:6/18/2013)... discovered and mapped the signaling network between two previously ... cut off cancer cell growth at its starting point. ... of Texas MD Anderson Cancer Center reported the tie ... drug target, and MCM7, a protein vital to the ... of Cancer Cell . , "MCM7 overexpression marks ...
(Date:6/18/2013)... 2013 The Elizabeth Glaser Pediatric AIDS ... the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) ... new milestones in the global effort to eliminate pediatric ... that as of June 2013, one million babies globally ... Since PEPFAR’s inception in 2003, EGPAF has been a ...
(Date:6/18/2013)... Healthcare Solutions , the parent ... today announced the appointment of Richard Leonardo to ... position, Leonardo will direct Healthcare Solutions’ national sales ... initiatives. , Recognized in the property and casualty ... more than 20 years of experience in business ...
Breaking Medicine News(10 mins):Health News:UT Dallas study suggests new approach to fight lung cancer 2Health News:UT Dallas study suggests new approach to fight lung cancer 3Health News:Scientists catch EGFR passing a crucial message to cancer-promoting protein 2Health News:One Million Babies Born HIV-free Signals Major Milestone in Global Effort to Eliminate Pediatric AIDS 2Health News:One Million Babies Born HIV-free Signals Major Milestone in Global Effort to Eliminate Pediatric AIDS 3Health News:Healthcare Solutions Appoints Richard Leonardo to Chief Sales Officer 2
... sexual adaptation shows that evidence is building for what ... appearing in Current Directions in Psychological Science, physical and ... males have evolved to deliver their sperm more effectively ... people are familiar with the idea of animals competing ...
... spider, a cousin to the well-known black widow, is increasingly ... is belongs to a group that is officially known as ... as "fiddleback" spiders or "violin" spiders because of the violin-shaped ... and thorax). ,The spiders are generally found in ...
... Union Minister of State for Environment and Forests, Shri ... century just as information technology dominated the last century. ... Consultative Committee of the Ministry of Environment and Forests, ... on Genetic Engineering Approval Committee has been vacated today ...
... In line with Ranbaxy Laboratories aggressive international expansion ... has solidified the acquisition of Be-Tabs Pharmaceuticals ... ,The deal is valued at R500 million ... fifth largest generic pharmaceutical company in South Africa. ...
... the champagne bottles which contained the weed killer that poisoned ... to him by a person well known to him-bowling coach Mustaq ... the team manager Talat Ali was witness to this. ... and Talat Ali knew the person or persons who handed over ...
... Concern over side effects of various drugs could be ... profile recalls like Vioxx, the osteoarthritis drug. ... Boston researchers at the Tufts-New England Medical Center. ... of Health Affairs, researchers compared half a dozen risky ...
Cached Medicine News:Health News:Louisiana Residents Warned Against Brown Recluse Spiders 2Health News:Biotechnology Will Dominate The 21st Century 2Health News:Ranbaxy Labs Extends Roots in South Africa 2Health News:Ranbaxy Labs Extends Roots in South Africa 3Health News:Drug Risks Must Be Balanced Against Benefits, Researchers 2
Attain Left-heart Lead Delivery Systems. Medtronic offers left-heart lead delivery systems to assist with accessing the coronary sinus (cs)....
Attain LV Leads. Navigate minimally angled veins with little to moderate tortuosity....
... Mitral bioprosthesis is a portrait ... based on 25 years of ... makes it an excellent choice ... replacement--particularly elderly patients and those ...
... Implantable defibrillators are used to treat ... life threatening. Implantable cardioverter defibrillators (ICDs) often ... (SCD), and have been found to reduce ... from as high as 55 percent to ...
Medicine Products: