Navigation Links
AcelRx Initiates a Phase 2 Study to Evaluate Functionality of Its ARX-01 Sufentanil NanoTab PCA System
Date:5/5/2009

REDWOOD CITY, Calif., May 5 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced that it has initiated a Phase 2 clinical trial of its ARX-01 Sufentanil NanoTab(TM) PCA System, a proprietary drug/device combination product candidate being developed for management of acute post-operative pain in the hospital setting. The primary objective of this open-label study is to assess the functionality of the ARX-01 System for post-operative pain management in patients undergoing unilateral knee replacement surgery.

AcelRx Chief Executive Officer, Thomas Schreck, commented, "We have successfully completed two placebo-controlled Phase 2 studies evaluating the efficacy and safety of Sufentanil NanoTabs in knee replacement and major abdominal surgery patients. Now with this third Phase 2 study we are validating the functionality of the handheld component of the ARX-01 Sufentanil NanoTab PCA System as we advance the ARX-01 clinical program."

Study investigator David Griffin, MD, of the Orthopaedic Center of Vero Beach, Florida stated, "I am excited about ARX-01; I believe it has the potential to address a large unmet medical need in the management of post-operative pain by allowing patients to manage their pain without the need for an IV line or complicated IV PCA pumps. Seeing the smooth, uneventful initiation of this first study utilizing the ARX-01 Sufentanil PCA System adds to the already compelling Phase 2 data that AcelRx announced in December."

About Acute Post-Operative Pain

Annually, approximately 8 million patients in the U.S. receive intravenous (IV) patient-controlled analgesia (PCA), typically utilizing morphine, for inpatient post-operative pain, with a similar number in the E.U. Despite its widespread use, the IV PCA architecture has several limitations. The IV line tethering the patient to the PCA pump discourages mobility, which is a critical factor in preventing post-operative complications and advancing recovery. Furthermore, the invasive nature of the IV delivery mode poses infection risk as well as predisposition to analgesic gaps due to infiltrated and dislodged IV catheters. Additionally, the complexity and programmability of IV PCA pumps introduce opportunities for medication errors, which in some instances may be fatal.

About ARX-01 Sufentanil NanoTab PCA System

ARX-01 is a novel drug/device combination product candidate designed for use in hospital settings to provide non-invasive patient-controlled analgesia and maximize patient satisfaction with post-operative pain management. The ARX-01 Sufentanil NanoTab PCA System avoids many of the limitations of IV PCA approaches by providing a non-invasive, pre-programmed, handheld PCA solution. The handheld component of ARX-01 allows for convenient patient self- administration of sufentanil NanoTabs sublingually for oral transmucosal absorption. Sufentanil is a high therapeutic index opioid approved for intravenous and epidural administration. Although the analgesic efficacy of sufentanil has been well established, its use has been limited due to its short IV plasma half-time. In the NanoTab oral transmucosal dosage form, sufentanil demonstrates a therapeutically appropriate pharmacokinetic profile for post-operative PCA usage and has the potential for improved patient tolerability over IV PCA morphine.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals is a privately held pharmaceutical company dedicated to the development and commercialization of new therapies for the treatment of pain and other conditions where there is an unmet need for improved safety and efficacy. The company applies its proprietary NanoTab dosage form and delivery technologies to enhance the safety, therapeutic benefit and commercial attractiveness of currently approved compounds. For additional information about AcelRx Pharmaceuticals visit http://www.acelrx.com.


'/>"/>
SOURCE AcelRx Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab(TM) Combination (ARX-03) in Treating Procedural Pain and Anxiety
2. BioMarin Initiates Phase 1/2 Clinical Trial for GALNS for Morquio A Syndrome
3. Dendreon Initiates Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer
4. VentiRx Pharmaceuticals Initiates Phase I Clinical Trial of VTX-1463, a Novel TLR8 Agonist for the Treatment of Allergic Rhinitis
5. Osprey Pharmaceuticals U.S.A., Inc. Initiates Phase Ib Clinical Trial in IgA Nephropathy
6. Pharmacyclics Initiates Phase 1 Clinical Trial of Novel Oral Btk Inhibitor for Refractory B-cell Non-Hodgkins Lymphoma
7. Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)
8. Radius Initiates Phase 2a Clinical Trial of RAD1901 in Menopausal Hot Flashes
9. Healthpoint Initiates Phase II, Dose-Finding Study to Evaluate Effectiveness of a Unique Cell Based Therapy in Venous Leg Ulcers
10. Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma
11. Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 /PRNewswire/ ... dringenden Bedarf zur Steuerung ... N.V. (NASDAQ: QGEN ; Frankfurt Prime ... Entwicklungsvereinbarung mit Therawis Diagnostics GmbH zur Entwicklung und ... sein. Ein erstes Projekt wird die Entwicklung und ...
(Date:5/25/2016)... , May 25, 2016  Zymo Research Corp. ... their new reference materials that help researchers obtain ... collection to analyses. The rapid growth of the ... researchers to have standard methods to improve the ... Biases inherently exist at every step of the ...
(Date:5/25/2016)... YORK , May 25, 2016 ... Market Size, Share, Development, Growth and Demand Forecast to ... Syringe, Insulin Pump and Others)" published by P&S Market ... at $9,998.3 million in 2015, and it is expected ... Based on type, the insulin pump segment is expected ...
Breaking Medicine Technology:
(Date:5/26/2016)... , ... May 26, 2016 , ... MadgeTech will be ... engineered, and manufactured in Warner, New Hampshire at the MadgeTech headquarters. With products sold ... monitoring solutions trusted by government agencies, including NASA. , In 2012, NASA strategically ...
(Date:5/26/2016)... ... 26, 2016 , ... An April Gallup survey found rising health care costs ... Sun Health Senior Living (SHSL) may not share those same worries thanks ... copays for the year, while holding the line on increasing their contributions, including premiums, ...
(Date:5/26/2016)... , ... May 26, 2016 , ... ... healthcare supply chain solutions, today announced the organization has earned its ISO 13485 ... standards and is compliant with all rules and policies associated with ISO quality ...
(Date:5/26/2016)... ... May 26, 2016 , ... North Cypress Medical Center hosted ... Club in Cypress. With the help of community partners, the event organizers raised $45,000 ... hope for wounded service members and their families through health, wellness, and therapeutic support. ...
(Date:5/26/2016)... ... ... The MIAMI Institute for Age Management and Intervention celebrates Global Wellness Day with ... Adonis , Wellness Physician of the MIAMI Institute is certified by the American Academy ... , He also heads up FITTLab, the comprehensive medical testing lab located in The ...
Breaking Medicine News(10 mins):