Navigation Links
AcelRx Announces Positive Phase 2 Results From a Study of ARX-02 Sufentanil NanoTab(TM) Breakthrough Pain Management System in Treating Cancer Breakthrough Pain
Date:5/25/2010

REDWOOD CITY, Calif., May 25 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical study evaluating the safety and efficacy of the ARX-02 Sufentanil NanoTab™ Breakthrough Pain Management System in the treatment of cancer breakthrough pain in opioid-tolerant patients. The primary endpoint of time-weighted Sum of the Pain Intensity Difference over the first 30 minutes after dosing (SPID-30) was highly statistically significant for ARX-02 compared to placebo (p < 0.001). Richard King, AcelRx President and Chief Executive Officer, commented, "AcelRx has now successfully completed Phase 2 studies with all three sufentanil-based development programs in progress at the company. These programs, targeting post-operative patient-controlled analgesia (ARX-01), outpatient procedural sedation (ARX-03) and now cancer breakthrough pain (ARX-02) represent important advances to meet significant unmet medical needs in these patient populations."

The initial open-label titration phase of the study enrolled 42 cancer patients with breakthrough pain. Of those patients, 36 (86%) were successful in titrating to an effective dose of ARX-02 with minimal side effects. In the double-blind, placebo-controlled phase of the study, titrated patients were randomized to receive a blinded sequence of seven doses of ARX-02 and three doses of placebo for use in treating ten distinct breakthrough pain events over the course of a three-week period. Patients recorded their pain intensity and pain relief scores for 60 minutes following administration of study drug or placebo using an electronic diary.

In addition to ARX-02 achieving statistical superiority over placebo on the SPID-30 primary endpoint, key secondary endpoints demonstrate that ARX-02 achieves rapid onset of analgesic efficacy in this patient population. For example, the time-weighted Total Pain Relief (TOTPAR) for ARX-02 separated from placebo at 10 minutes (p = 0.049), the earliest time point recorded. In addition, there was no statistical difference in the frequency of any class of adverse events between ARX-02 and placebo treatments.

Pamela Palmer, MD, PhD, AcelRx Chief Medical Officer stated, "Sufentanil, the active agent in ARX-02, is a highly lipophilic drug with rapid transit time to the brain effector sites. The early onset of analgesia demonstrated by significant pain relief as early as 10 minutes in this study suggests that ARX-02 is ideal for the indication of breakthrough pain. In addition, the shorter plasma half-life seen with ARX-02 more closely matches effective opioid levels to the duration of a breakthrough pain event compared to commercially available fentanyl-based breakthrough pain products."

About Cancer Breakthrough Pain

Many patients with cancer-related pain are treated chronically with pain medication, but still experience episodes of severe pain that "breaks through" this base level of pain control. Typically the pain flare occurs with rapid onset and lasts approximately 15-60 minutes. Patients may experience several of these breakthrough pain episodes per day. Currently, oral transmucosal fentanyl-based products are the only approved treatments for cancer breakthrough pain. These products have prolonged plasma half-lives that extend well beyond four hours for most dosage strengths and due to their varying pharmacokinetics, patients may experience variable onset of analgesia.

About ARX-02

AcelRx is developing ARX-02, a novel sublingual Sufentanil NanoTab product candidate, as a new treatment option for patients with cancer breakthrough pain. Sufentanil is a strong opioid that is approximately 5-10 times more potent than fentanyl, yet has an 80-fold wider safety margin (therapeutic index), as determined in animal studies. The NanoTab is a very small tablet designed to allow rapid uptake of sufentanil following placement under the tongue, maximizing transmucosal drug uptake and limiting the proportion of swallowed drug. ARX-02 enables rapid onset of pain relief with a consistent, relatively short duration of action, more closely matching the timing of a breakthrough pain episode.

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©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AcelRx to Present at the Lazard 6th Annual Healthcare Conference
2. AcelRx Programs to be Featured in Oral Presentations at the American Society of Anesthesiologists 2009 Annual Meeting
3. AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain
4. AcelRx Initiates a Phase 2 Study to Evaluate Functionality of Its ARX-01 Sufentanil NanoTab PCA System
5. AcelRx Pharmaceuticals Reports Positive Results from a Clinical Trial of Sublingual Sufentanil/Triazolam NanoTab(TM) Combination (ARX-03) in Treating Procedural Pain and Anxiety
6. ProUroCare Medical Announces Filing of Request to Classify the Prostate Mechanical Imager ("PMI") as a Class II Device
7. Applied Precision Announces New Products for Life Sciences Microscopy at the 110th American Society for Microbiology Meeting in San Diego, CA, May 23-26th.
8. Hisamitsu Pharmaceutical Announces Two New FDA Approved Over-The-Counter Pain Relief Patches
9. Fred A. Baughman Jr., MD Announces: Vets Deaths Are Not Suicides or Overdoses but Sudden Cardiac Deaths Due to Prescription Antipsychotics and Antidepressants
10. Volcano Announces Plans to Introduce Multiple New Products at EuroPCR 2010
11. Epix Pharmaceuticals, Inc. Announces a Change in the May 28, 2010 Auction Sale of Epix Imaging Agents to June 22, 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... Jan. 19, 2017 Report Details ... Which areas are going to grow at the fastest ... 2026, assessing data, trends, opportunities and prospects. Our ... the most lucrative areas in the industry and the ... forecasted sales across the all the major categories of ...
(Date:1/19/2017)... SILVER SPRING, Md. , Jan. 19, 2017 ... for the treatment of Chronic Idiopathic Constipation (CIC) in adult ... patients suffering from chronic gastrointestinal disorders," said Julie Beitz ... in the FDA,s Center for Drug Evaluation and Research. "With ... select the most appropriate treatment for their condition." ...
(Date:1/19/2017)... Jan. 19, 2017 Report Details ... Alzheimer,s ... Leading Companies – our new study reveals trends, R&D ... and events affecting the Alzheimer,s disease therapeutics and diagnostics ... these key questions: - How is the Alzheimer,s disease ...
Breaking Medicine Technology:
(Date:1/21/2017)... Raton, FL (PRWEB) , ... January 21, 2017 , ... ... eRaiser, recently attended the January ECRM Trade Show in Hilton Head, SC, where it ... international reputation for the quality of its beauty and wellness products. At this trade ...
(Date:1/21/2017)... ... ... is the perfect set of tools for video editors that want to create the illusion ... - CEO of Pixel Film Studios. , Video editors using ProDOF can add realistic ... racking focus from one area into the next. ProDOF comes with 0.5 second, 1.0 ...
(Date:1/21/2017)... ... January 21, 2017 , ... Phytocéane invites ... isolated from the rest of the world with ZANZIBAR SHOWER GEL. Inspired by the ... key ingredients, Virgin Coconut Oil and moisturizing vegetal coral to create this gentle, crystal-clear ...
(Date:1/21/2017)... ... January 21, 2017 , ... ... Family Dermatology has recently joined their multi-specialty medical group. The dermatology practice ... cosmetic services. , “We’re excited to add this excellent dermatology practice to our ...
(Date:1/21/2017)... ... January 21, 2017 , ... In the United States, 20 ... the freedom of recovery, they often feel shame for having struggled with an eating ... (PTSD). In the workshop, “Rising Strong in Life After an Eating Disorder” -- to ...
Breaking Medicine News(10 mins):