Navigation Links
Top-line Data Show AcelRx Pharmaceuticals' ARX-04 Achieves Primary Endpoint in Dose-Finding Phase 2 Clinical Trial
Date:4/24/2013

eneral for patients in moderate-to-severe acute pain where intravenous access is not readily available."

This study randomized 101 patients following bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg sufentanil or placebo treatment arms.  The intent-to-treat (ITT) population in this study averaged 42.5 years of age with an average Body Mass Index of 28.2, and was evenly balanced for males and females (51%:49%) and ethnicity (54% Caucasian:46% non-Caucasian).  Ninety-one percent of patients entering the study completed the full 12-hour study period.  SPID-12 scores were +6.53 for 30 mcg sufentanil-treated patients and -7.12 for placebo-treated patients, the difference between the two groups being highly statistically significant (p=0.003).  The 20 mcg sufentanil-treated patients did not achieve SPID-12 scores that differentiated from placebo.

"The results from this study, funded by the U.S. Army Medical Research and Materiel Command, provide further validation of our sufentanil NanoTab product platform as an effective treatment for moderate-to-severe acute pain," said Richard King , president and CEO of AcelRx. "AcelRx will present these positive top-line data to USAMRMC, and intends to hold an End of Phase 2 meeting with the FDA to define the Phase 3 clinical program for ARX-04."

About ARX-04

ARX-04 is a product candidate in development for the treatment of moderate-to-severe acute pain, consisting of sufentanil, a high therapeutic index opioid, in AcelRx's proprietary NanoTab technology that enables rapid sublingual absorption when the NanoTab is placed under the tongue.  As a result, sufentanil NanoTabs are designed to provide rapid onset of analgesia in a non-invasive method of administration and display a consistent pharmacokinetic profile due to a high percentage of drug being absorbed sublingually instead of through the gastrointestinal tract.  We believe
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. Sinovac EV71 Vaccine Phase III Top-Line Results Presented at 13th Annual World Vaccine Congress & Expo
2. AstraZeneca Announces Top-Line Results From OSKIRA-1 Phase 3 Study of Fostamatinib in Rheumatoid Arthritis
3. Merrimack Pharmaceuticals Announces Top-Line Results From A Single Arm Phase 2 Advanced Lung Cancer Study In Patients With Resistance To An Anti-EGFR Tyrosine Kinase Inhibitor
4. 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
5. Intra-Cellular Therapies Announces Completion of Phase I Single Rising Dose Trial of First-in-Class Selective Phosphodiesterase 1 (PDE1) Inhibitor and Reports Top-line Safety and Pharmacokinetic Findings
6. AstraZeneca Announces Top-Line Results of OSKIRA-4 Phase IIb Study of Fostamatinib as a Monotherapy for Rheumatoid Arthritis
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. Vermillion Announces Positive Top-Line Results from the OVA500 Multi-Center Study Led by UC Irvine
9. Top-line Data From Phase 3 Trial of Ataluren in Patients with Nonsense Mutation Cystic Fibrosis Show Promising Results
10. Amgen Announces Top-Line Results Of Phase 3 Sensipar®/Mimpara® EVOLVE™ Trial
11. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... 30, 2015 Future Market Insights ... "Continuous Glucose Monitoring Systems Market: Global Industry Analysis and ... the global continuous glucose monitoring systems market was valued ... to reach US$ 788.4 Mn by 2020, registering a ... 2020. Global continuous glucose monitoring systems market ...
(Date:7/30/2015)... , July 30, 2015  Medimetriks Pharmaceuticals, Inc. ... second Phase III clinical study for Ozenoxacin, a ... Medimetriks owns the exclusive U.S. rights to Ozenoxacin ... conducted at 44 centers with an emphasis on ... aged 2 months and older with a clinical ...
(Date:7/30/2015)... July 30, 2015   Gaumard® Scientific Company ... UNI®, the world,s first operating system to support ... available exclusively to Gaumard users. UNI® version 2.27.21.0 ... Newborn Tory™ S2200, as well as improvements to ... clinical measures such as EtCO 2 .  ...
Breaking Medicine Technology:Global Continuous Glucose Monitoring (CGM) Systems Market: Transmitters and Monitors Most Dominant Segment, Says Future Market Insights 2Global Continuous Glucose Monitoring (CGM) Systems Market: Transmitters and Monitors Most Dominant Segment, Says Future Market Insights 3Global Continuous Glucose Monitoring (CGM) Systems Market: Transmitters and Monitors Most Dominant Segment, Says Future Market Insights 4Medimetriks Pharmaceuticals, Inc. Announces Completion of the Second Successful Pivotal Phase III Study for Ozenoxacin 2Medimetriks Pharmaceuticals, Inc. Announces Completion of the Second Successful Pivotal Phase III Study for Ozenoxacin 3Gaumard's Latest UNI Operating System Update Adds Performance and New Functionality 2Gaumard's Latest UNI Operating System Update Adds Performance and New Functionality 3
... WASHINGTON, Sept. 29, 2011 As small businesses struggle ... indicates concern that forthcoming Essential Health Benefits regulations ... drug companies to raise prescription drug costs, the ... benefit managers (PBMs) administer drug benefits for thousands of ...
... 29, 2011 A drug recently approved by the U.S. ... targets a malfunctioning gene discovered more than a decade earlier ... scientific findings from St. Jude can be translated into therapies ... adults. The drug is Xalkori (crizotinib). The FDA ...
Cached Medicine Technology:Some Essential Benefits Rules Could Worry Small Businesses 2St. Jude Children's Research Hospital Discovery Aided Quest for Adult Cancer Drug 2St. Jude Children's Research Hospital Discovery Aided Quest for Adult Cancer Drug 3
(Date:7/31/2015)... ... July 31, 2015 , ... Precision Aesthetics is New York’s ... It was also the first provider of Exilis non-surgical fat reduction in New York. ... it has attracted a large International clientele. Many patients travel to New York ...
(Date:7/31/2015)... ... 31, 2015 , ... Last week, the Mesothelioma Applied Research ... be accessed by visiting http://www.curemeso.org/store . , “Our new store features a ... whenever a product is purchased, the Meso Foundation receives a $5.00 donation,” said ...
(Date:7/31/2015)... ... 31, 2015 , ... Sculpted Contours Luxury Medical Aesthetics announces the arrival of ... Aesthetics released this new applicator in the United States as an upgrade to the ... The original applicator required a 2 hour treatment time. The new CoolSmooth ...
(Date:7/31/2015)... ... July 31, 2015 , ... ... workshop at its new True North Conference Center. The medical community, social workers, ... Jacksonville community may be more aligned in the effort to better understand and ...
(Date:7/31/2015)... ... July 31, 2015 , ... Coco Libre announced today that their flagship Organic ... the 2015 Vans US Open of Surfing, July 25 through August 2 in Huntington ... sugar” on the market, is a natural choice given the Open’s commitment to sustainable ...
Breaking Medicine News(10 mins):Health News:Mesothelioma Organization Launches New Store 2Health News:Mesothelioma Organization Launches New Store 3Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 3Health News:Lakeview Health Links Sex Trafficking and Addiction in Special Jacksonville Educational Workshop 2Health News:Lakeview Health Links Sex Trafficking and Addiction in Special Jacksonville Educational Workshop 3Health News:Coco Libre Brings Eco-conscious Hydration to Vans US Open of Surfing 2
... known that pregnant women who develop pre-eclampsia, which are a ... the risk of having a stroke during pregnancy. // ... Centres for Disease Control and Prevention now report that pre-eclampsia ... ,Dr David W. Brown and colleagues in Atlanta used ...
... rejected the UN findings that claim an extra 4,000 cancer ... Chernobyl disaster,// which struck 20 years ago. Instead, the group ... 93,000. ,Most of these victims would ... in April 1986 was one of the worst nuclear accidents ...
... Generally Vitamin D is found in either sunrays or in ... for that. // The research says that brief UV exposure ... D. The Food and Drug Administration proposed study is being ... to the concern with the vitamin deficiency. It would be ...
... died and up to 25,000 affected in a malaria epidemic in ... fanned out to take preventive steps and cure those hit by ... ,The minister said 50 people had died of cerebral malaria since ... Golaghat being the worst hit. ,"We have been able ...
... April issue of Archives of Dermatology, almost 50% of high ... their newspapers. // Tanning advertisements have been found in newspapers ... were about 40 tanning advertisements, 15 of whom did speak ... months. ,The article carries related information about the ...
... the lifestyle and socioeconomic status of 422 students with reference ... who lack sleep tend to be overweight //. ... Laval's faculty of medicine and was based on a telephonic ... children’s body mass index revealed that 24% of the girls ...
Cached Medicine News:
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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 ...
Medicine Products: