Navigation Links
AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab(TM) Combination (ARX-03) in Treating Procedural Pain and Anxiety
Date:1/12/2009

Results Show Successful Clinical Validation of Pharmacodynamic Effect

REDWOOD CITY, Calif., Jan. 12 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc., an emerging specialty pharmaceutical company focused on the treatment of intermittent and acute medical conditions with an initial emphasis on pain management, today announced positive results from a Phase 1 clinical study evaluating the safety, tolerability and efficacy of the company's proprietary sublingual sufentanil (opioid) and triazolam (benzodiazepine) NanoTab(TM) combination product candidate (ARX-03). The product is designed to address the current unmet need for a non-invasive product to provide sedation and analgesia for an increasing number of office-based procedures.

The study demonstrated that administration of ARX-03 resulted in a statistically significant increase in sedation levels for the 10mcg sufentanil/200mcg triazolam dosage strength in both a younger cohort (age range 18-60 years; p=0.009) and an older cohort (age range of 61-80 years; p=0.003) as compared to sublingual sufentanil alone. These data were collected using the Richmond Agitation-Sedation Scale (RASS), a validated and objective test for assessment of sedation levels. The average onset of sedation was 20-30 minutes for the higher dosage strength in each study cohort.

Additionally, sublingual administration of the sufentanil/triazolam combination was found to be safe and well tolerated. Based on these positive results, AcelRx intends to further advance clinical development of ARX-03 in 2009.

"We believe the results of this trial are particularly valuable as they offer clinical evidence well beyond what is expected from a typical Phase 1 study. Not only have we shown ARX-03 to be safe and well-tolerated, we have also demonstrated significant pharmacodynamic findings with a randomized, double-blind design that spanned different age groups and multiple dosage levels," said Pamela Palmer, M.D., Ph.D., chief medical officer of AcelRx Pharmaceuticals.

This 24-patient two-cohort, five-arm crossover study included administration of open-label oral triazolam and IV sufentanil on days one and two followed by a double-blinded, randomized dosing of a sublingual NanoTab(TM) containing high-dose sufentanil/triazolam, low-dose sufentanil/triazolam and 10mcg sufentanil only on days three to five.

ARX-03 is designed to provide analgesia, anxiolysis and mild sedation without requiring the presence of an anesthesiologist, in a safe, simple, non-invasive form for use in procedural settings. The product is based on the company's proprietary NanoTab(TM) dosage form, which enables delivery of the sufentanil/triazolam combination by the non-invasive oral transmucosal (sublingual) route, resulting in high drug bioavailability but significantly lower and safer peak plasma levels than IV.

"The very positive data generated from this study validates the clinical applicability of this product concept from both a safety and efficacy point of view, and further underscores the commitment of AcelRx to advance the clinical development of this program," said Thomas A. Schreck, chairman and chief executive officer of AcelRx Pharmaceuticals. "The positive findings that AcelRx recently announced regarding our lead product candidate, ARX-01, combined with the impressive data from this ARX-03 study demonstrate the breadth and value of the AcelRx pipeline and strongly positions the company for future success."

About ARX-03 Sublingual Sufentanil/Triazolam NanoTab(TM) Combination for Procedural Pain and Anxiety

Procedural pain and anxiety in the doctor's office and clinic setting represents a significant unmet medical need for patients and healthcare providers. Most physician's offices and clinics cannot provide appropriate staffing for IV sedation, often resulting in patients experiencing high levels of pain and anxiety. Ideal treatment of procedural pain and anxiety minimizes patient awareness and discomfort, while maintaining patient safety. A preferred product candidate for treatment of procedural pain and anxiety should possess sedative, analgesic and amnestic properties, be safe, easy to use and administered via a non-invasive route, and have a rapid onset and a sufficient duration of action which allows for rapid recovery and discharge. AcelRx's novel ARX-03 sublingual NanoTab(TM) is designed to satisfy these criteria.

AcelRx is preparing to initiate a Phase 2a clinical trial to further evaluate the safety and efficacy of ARX-F03 for treatment of procedural pain and anxiety.

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 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. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 The vast majority of dialysis patients ... Treatments are usually 3 times a week, with treatment ... travel time, equipment preparation and wait time.  This regimen ... for patients who are elderly and frail.  Many elderly ... rehabilitation centers for some duration of time. ...
(Date:6/23/2016)... June 23, 2016  Experian Health, the ... transforming the patient payment and care experience, ... new products and services that will enhance ... cycle offerings. These award-winning solutions will enable ... remain compliant in an ever-changing environment and ...
(Date:6/23/2016)...  The National Pharmaceutical Council (NPC) today announced ... research organization as its newest member.  ... president and chief scientific officer, Mallinckrodt Pharmaceuticals, will ... Board of Directors. ... us in support of our efforts to conduct ...
Breaking Medicine Technology:
(Date:6/27/2016)... , ... June 27, 2016 , ... ... mental health professionals, announced today its affiliation with Tennessee Counseling Association. ... to the network of the Tennessee Counseling Association, adding exclusive benefits and promotional ...
(Date:6/27/2016)... Park, KS (PRWEB) , ... June 27, 2016 , ... ... in retailers of Eyeglasses . , Millions of individuals in the United States ... eyeglasses have become a way to both correct vision and make a fashion statement. ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice ... "Film editors can give their videos a whole new perspective by using the ... of Pixel Film Studios. , ProSlice Levels contains over 30 Different presets to ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
Breaking Medicine News(10 mins):