Navigation Links
AcelRx Top-line Data Show Primary Endpoint Achieved in Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Post-Operative Pain in Major Open Abdominal Surgery Patients
Date:3/4/2013

o-controlled design, this pivotal Phase 3 study enrolled 178 adult patients at 13 U.S. sites for the treatment of acute post-operative pain immediately following major abdominal surgery.  Patients were treated for post-operative pain for a minimum of 48 hours, and up to 72 hours.  Patients were randomized 2:1, with 119 patients randomized to sufentanil and 59 to placebo treatment.  Both treatments were delivered by the patient, as needed, using the NanoTab System with a 20-minute lock-out period.  Patients in both groups could receive up to 2 mg morphine intravenously per hour as a rescue medication, the primary purpose of this rescue medication being to provide placebo-treated patients access to pain medication to enable them to stay in the study as long as possible.  Pre-rescue pain scores were imputed to minimize the impact of this rescue opioid on efficacy evaluations.

Eighty, or 70.2% of the sufentanil NanoTab-treated patients completed the 48-hour study period, compared to 30 (51.7%) placebo-treated patients.  Reasons for drop-out in the sufentanil- and placebo-treated groups were adverse events (5.3% and 6.9% respectively), lack of efficacy (16.7% and 31.0% respectively) and other (7.9% and 10.3% respectively).  The primary endpoint measure, SPID-48, was 105.6 for sufentanil-treated patients and 55.6 for placebo-treated patients (p=0.001). 

Treatment-emergent adverse events occurred in 64.0% of sufentanil-treated patients and 67.2% of placebo-treated patients.  Adverse events with an occurrence greater than 5% in either the sufentanil group or the placebo group were nausea (30.7% and 41.4% respectively), fever (14.9% and 8.6% respectively), vomiting (8.8% and 6.9% respectively), itching (8.8% and 0.0% respectively), oxygen saturation decrease (6.1% and 1.7% respectively), and hypertension (2.6% and 5.2% respectively).  Itching, a frequently observed side effect of opioids, was the only adverse e
'/>"/>

SOURCE AcelRx Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. AcelRx Pharmaceuticals to Present at Two Upcoming Investor Conferences
2. AcelRx Pharmaceuticals Provides Clinical Trial Updates
3. AcelRx Appoints Adrian Adams to Board of Directors as Chairman
4. AcelRx Pharmaceuticals Announces Pricing of Public Offering of Common Stock
5. AcelRx Pharmaceuticals Announces Proposed Public Offering Of Common Stock
6. AcelRx Pharmaceuticals to Present at the Piper Jaffray 24th Annual Healthcare Conference
7. AcelRx Announces Achievement of the Primary End-Point in Phase 3 Comparative Study Involving the Sufentanil NanoTab PCA System and Plans to Hold a Conference Call and Webcast Tomorrow to Discuss Top-Line Results
8. AcelRx Pharmaceuticals Reports Third Quarter 2012 Financial Results
9. AcelRx Pharmaceuticals Doses the First Patients in ARX-04 Phase 2 Clinical Study
10. AcelRx Pharmaceuticals to Hold Third Quarter 2012 Financial Results Conference Call and Webcast on November 6, 2012
11. AcelRx Pharmaceuticals Hires Mike A. Royal, M.D. as Chief, Clinical Affairs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... 2015  Pete Rose, baseball,s all-time hits leader, is the new ... Myoflex, Ducere Pharma has announced. "Pete,s a Hall ... have him on board with Myoflex," said Ducere Pharma Chief ... player who is known across all generations. The passion and ...
(Date:1/23/2015)... Cord Blood America, Inc. ( www.cordblood-america.com ) (OTC Bulletin Board: ... Preliminary Proxy Statement, Schedule 14A, with the U.S. Securities & ... for shareholders detailing why a "YES" vote to increase the ... As we reflect upon the 2014 fiscal year ...
(Date:1/23/2015)... LONDON and BOSTON , January ... structure-guided drug discovery and development company, is delighted to announce ... has been awarded to Miles Congreve (Vice President ... co-founder) and Malcolm Weir (Chief Executive Officer and ...
Breaking Medicine Technology:Pete Rose bets on Myoflex to relieve aches and pains 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 3Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 4Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 2Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 4
... Five Star Healthcare™, a division of Crump Insurance Services, ... largest insurance wholesaler, today announced it has added a ... The program, offered through an A.M. Best A XI ... needs of dialysis providers.  Operations of any size are ...
... CINCINNATI, May 12, 2011 Kendle (Nasdaq: KNDL ... announced it is ranked a "top CRO to work with" ... the only CRO to be ranked consistently among the top ... the annual investigative site surveys conducted by the leading clinical ...
Cached Medicine Technology:Exclusive Coverage for Kidney Dialysis Centers Offered by Five Star Healthcare 2Kendle Rated a "Top CRO to Work With" for Fifth Consecutive Year 2Kendle Rated a "Top CRO to Work With" for Fifth Consecutive Year 3Kendle Rated a "Top CRO to Work With" for Fifth Consecutive Year 4Kendle Rated a "Top CRO to Work With" for Fifth Consecutive Year 5
(Date:1/22/2015)... La Jolla, Calif. (PRWEB) January 22, 2015 ... and Assemblymembers Susan Bonilla (D-Concord) and Kristin Olsen ... (CHI) for their leadership in advancing biotechnology, biomedical ... Mitchell, Bonilla and Olsen each received the “2014 ...
(Date:1/22/2015)... Colorado (PRWEB) January 22, 2015 Four years since ... Queen – which coincided with the marriage of Avasa & Matthew ... THE ROAD, which is scheduled for release through White Swan Records ... message that there is a sacred path available to all of ...
(Date:1/22/2015)... January 22, 2015 As interest in the ... care gains momentum worldwide, Rev. Eric J. Hall , ... Network (HCCN), will be the keynote speaker on January ... Israel’s public health system. , The conference, “Hope and Resilience: ...
(Date:1/22/2015)... released a new blog post explaining the importance of keeping a ... of an auto insurance policy . , Clients who driver ... their vehicle insurance policies. The safety a vehicle offers from its ... of this, drivers should always carry a first aid kit in ...
(Date:12/26/2014)... The US represents the largest market for CRC across the ... that sales of branded therapies were $2.23 billion. The US ... of the disease, high drug treatment rate, and higher drug ... of CRC therapies over the forecast period will be driven ...
Breaking Medicine News(10 mins):Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:Driving Safe And Other Factors That Make Auto Insurance Affordable! 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 3Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 4
... to announce TRIZCON2008, a conference that focuses on the ... anniversary, the largest international TRIZ conference in the world ... Universitys Student Center in Kent, Ohio, from April 13-15, ... new and experienced users to get an in-depth introduction ...
... 19 With sales forces shrinking,across the pharmaceutical ... rep time, winning a place on hospital formularies ... companies are relying on,specialized training classes to help ... hospital environment, according to recent,research from pharmaceutical benchmarking ...
... Robin Nasatir,has been promoted to President/Chief Operating Officer ... valued team of project,leaders who help organizations improve ... with the firm,s celebration of 35,years in business ... and operated enterprise., "Robin and I have ...
... NEW YORK (Feb. 19, 2008) -- A longstanding puzzle in ... team led by scientists at Weill Cornell Medical College says ... the developing neuron,s long, skinny axon affect gene transcription back ... the first-ever evidence of a transcription factor -- proteins that ...
... In response to recent media,reports, Roche would like to ... antiviral medication for the 2007-2008,flu season, and that physicians ... if flu strikes., Some news reports have indicated ... measures in place to ensure that Tamiflu is readily,available. ...
... controls the production and activation of granulocytes, white ... pathogens. , Relevance: This is the first microRNA ... innate immune response. Absence of microRNA-223 increased the ... inflammation and damage. Increased production of microRNA-223 may ...
Cached Medicine News:Health News:TRIZCON2008 at Kent State, April 13-15 2Health News:Building an Effective Sales Force to Serve the U.S. Hospital Market 2Health News:Cliff Consulting, Inc. Transitions to Woman-Owned and Managed Firm With Robin Nasatir's Promotion to President/Chief Operating Officer 2Health News:Scientists shed light on long-distance signaling in developing neurons 2Health News:Scientists shed light on long-distance signaling in developing neurons 3Health News:Press Statement: Roche Affirms That Tamiflu(R) is in Ample Supply Nationwide 2Health News:Single microRNA fine-tunes innate immune response 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: