Navigation Links
AcelRx Pharmaceuticals Reports Positive Results From a Phase 2 Clinical Trial of Sublingual Sufentanil NanoTabs(TM) in Treating Post-Operative Pain
Date:12/9/2008

REDWOOD CITY, Calif., Dec. 9 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical study evaluating the safety and efficacy of its lead product candidate, ARX-01, for the treatment of moderate-to-severe inpatient acute pain following knee replacement surgery. The primary endpoint evaluated pain intensity (Sum of the Pain Intensity Difference - SPID12) over the 12-hour study period compared to baseline. Results demonstrated that compared to placebo, patients receiving 15 mcg of ARX-01 experienced a statistically significant reduction in pain intensity over the study period, based on the worst observation carried forward imputation method (WOCF), p=0.015. Additionally, at the 15 mcg dose, the study met an important secondary endpoint compared to placebo, the percentage of patient dropouts due to inadequate analgesia, p=0.006. Further, no serious or unexpected adverse events related to ARX-01 were reported in the study.

ARX-01 is a sublingual formulation of the opioid pain medication, sufentanil. ARX-01 is based on the company's proprietary NanoTab(TM) dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route.

"We chose a very painful surgery in an elderly patient population to showcase the efficacy and safety of Sublingual Sufentanil NanoTabs in treating acute post-operative pain," said Pamela Palmer, M.D., Ph.D., chief medical officer of AcelRx Pharmaceuticals. "The superior attributes of both the drug and the dosage form enabled these highly encouraging Phase 2 results."

This multicenter, double-blind, randomized, placebo-controlled, dose-finding Phase 2 study evaluated the safety and efficacy of ARX-01 in patients undergoing elective unilateral knee replacement surgery. In the study, 101 patients were randomized to receive either placebo or one of three different dosage strengths of ARX-01: 5mcg, 10mcg or 15mcg of sufentanil. Doses were delivered sublingually as needed to treat pain with a 20-minute minimum re-dosing interval and patients were allowed to drop out of the study at any time. Positive results were also obtained for the primary endpoint following treatment with the 15mcg dose compared to placebo using two alternate methods for imputing missing data from drop-outs: baseline observation carried forward (BOCF), p = 0.007, and last observation carried forward (LOCF), p = 0.018. Importantly, there were no events of clinically significant respiratory depression for any dosing group. Based on these positive results, AcelRx intends to further advance clinical development of ARX-01 in 2009.

"We are pleased by the wonderful clinical results of our Phase 2 post-operative acute pain study," said Thomas A. Schreck, chairman and chief executive officer of AcelRx Pharmaceuticals. "This is the culmination of a great deal of hard work by a team of efficient, dedicated people over the last two years, and is therefore very gratifying indeed. This trial has the benefit of validating Sublingual Sufentanil NanoTabs as a robust product candidate for its initial in-hospital acute pain indication, as well as providing the foundation of safety and efficacy for the other programs in our pipeline."

About ARX-01 Sublingual Sufentanil NanoTabs

Sufentanil is currently approved as an intravenous (IV) anesthetic and is also indicated for epidural administration during labor and delivery. Due to their small size, ARX-01 Sublingual Sufentanil NanoTabs are convenient, well-tolerated, have high bioavailability and provide lower peak plasma levels compared to IV administration.

About the ARX-01 Oral Patient-Controlled Analgesia System

The ARX-01 Oral Patient-Controlled Analgesia (PCA) system is based on a proprietary pre-programmed, hand-held dispenser being developed by AcelRx. The AcelRx dispenser is designed to be hospital compliant for administration of Sublingual Sufentanil NanoTabs, while providing features directed to patient safety and convenience.

About Acute In-Hospital Pain

Acute pain management in the hospital, in particular post-operative analgesia, remains a significant challenge for healthcare providers. Current treatment methods include IV PCA, continuous epidural infusion, as well as other regional anesthesia techniques. IV PCA relies on a computerized pump that is attached to a patient's IV catheter. A variety of opioids, most frequently morphine, may be patient-administered via the PCA pump. The invasive nature of IV PCA delivery and the potential for programming errors when setting up the pump are well-known disadvantages of this method of pain control.

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©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
2. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
3. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
4. XTL Biopharmaceuticals Announces Financial Results for the Six Months Ended June 30, 2007
5. Cadence Pharmaceuticals Reports Second Quarter 2007 Financial Results
6. Nabi Biopharmaceuticals to Present at Upcoming Industry Conferences
7. Anadys Pharmaceuticals Appoints Steve Worland, Ph.D. as President and Chief Executive Officer
8. Poniard Pharmaceuticals Announces Participation in Upcoming Conferences
9. NovaQuest Advances Virtual Development Model With Strategic Investment in TOPIGEN Pharmaceuticals
10. Drug Royalty Corporation (DRC) Announces Acquisition Regarding PEG-INTRON(R) From Enzon Pharmaceuticals, Inc. (ENZN)
11. Sunesis Pharmaceuticals Announces Reorganization to Focus Resources and Build Value in Clinical-Stage Programs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the ... the Supplyframe Design Lab . Located in Pasadena, Calif., the Design Lab’s ... how hardware projects are designed, built and brought to market. , The Design ...
(Date:6/23/2016)... , June 23, 2016 Apellis Pharmaceuticals, ... 1 clinical trials of its complement C3 inhibitor, ... and multiple ascending dose studies designed to assess ... of subcutaneous injection in healthy adult volunteers. ... either as a single dose (ranging from 45 ...
(Date:6/23/2016)... , June 23, 2016 On Wednesday, ... at 4,833.32, down 0.22%; the Dow Jones Industrial Average edged ... closed at 2,085.45, down 0.17%. Stock-Callers.com has initiated coverage on ... ), Nektar Therapeutics (NASDAQ: NKTR ), Aralez Pharmaceuticals ... (NASDAQ: BIND ). Learn more about these stocks ...
(Date:6/23/2016)... ... June 23, 2016 , ... Velocity Products, ... tools designed, tuned and optimized exclusively for Okuma CNC machining centers at The ... of a collaboration among several companies with expertise in toolholding, cutting tools, machining ...
Breaking Biology Technology:
(Date:5/9/2016)... , UAE, May 9, 2016 ... it comes to expanding freedom for high net worth ... Even in today,s globally connected world, there is still ... system could ever duplicate sealing your deal with a ... second passports by taking advantage of citizenship via investment ...
(Date:4/26/2016)... , April 27, 2016 ... the  "Global Multi-modal Biometrics Market 2016-2020"  report to ... ) , The analysts forecast the ... CAGR of 15.49% during the period 2016-2020.  ... number of sectors such as the healthcare, BFSI, ...
(Date:4/13/2016)... April 13, 2016  IMPOWER physicians supporting Medicaid patients ... a new clinical standard in telehealth thanks to a ... the higi platform, IMPOWER patients can routinely track key ... body mass index, and, when they opt in, share ... visit to a local retail location at no cost. ...
Breaking Biology News(10 mins):