AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain
Posted on: Monday, 29 June 2009, 06:00 CDT
Study in major abdominal surgery patients achieved primary and secondary endpoints
This multicenter, double-blind, placebo-controlled study included 88 patients undergoing major abdominal surgery randomized to receive either 10 mcg or 15 mcg doses of ARX-01, or placebo for post-operative pain. Study drug was administered sublingually, as needed to treat pain with a minimum re-dosing interval of 20 minutes. Patients were allowed to drop out of the study at any time. The primary efficacy endpoint was SPID-12 (a cumulative measure of the difference in pain intensity over the 12-hour study compared to baseline). Both ARX-01 10 mcg and 15 mcg treatment groups showed statistically significant reductions in pain intensity over the study period (p<0.001 for each) based on the last observation carried forward imputation method, with similar results for alternate imputation methods (worst and baseline observations carried forward). Additionally, the proportion of patients who dropped out due to inadequate analgesia, a clinically meaningful secondary endpoint, was also significantly different from placebo (p<0.001) for both treatment groups. ARX-01 was well tolerated; the most common adverse event reported was mild to moderate nausea with similar incidence between all treatment groups (including placebo). There were no serious adverse events related to study drug.
Study investigator, anesthesiologist Dr.
The current data support the previously reported positive results for ARX-01 from the first Phase 2 study which evaluated the safety and efficacy of ARX-01 Sufentanil NanoTabs in patients undergoing elective unilateral knee replacement surgery. Additionally, an open-label Phase 2 study is currently ongoing with the primary objective of assessing the functionality of the handheld device component of the ARX-01 Sufentanil NanoTab PCA System in patients undergoing unilateral knee replacement surgery.
AcelRx Chief Medical Officer,
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.
Source: PR Newswire
Related Articles
- Newly Published Clinical Data Shows Caldolor(R) (Ibuprofen) Injection Reduces Opioid Use While Improving Pain Relief in Post-Operative Patients
- Certain Cancers More Common Among HIV Patients Than Non-HIV Patients
- Pennsylvania Patient Safety Authority Hires Patient Safety Liaison (PSL) to Help Healthcare Facilities Implement Guidance
- Surgical Groups Form 'Operation Patient Access: Quality Surgical Care for All' to Call Attention to Escalating Workforce Shortage
- Array BioPharma Reports Positive Results From Phase II Dental Pain Study
- Head-to-Head 96-Week Study Shows EPZICOM(R) is Comparable to Truvada(R) in Efficacy and Safety Measures in HIV Treatment-Naive Patients
- Altus Pharmaceuticals Reports Last Patient Visit Of Trizytek(TM) Phase 3 Efficacy Trial
- Qualitative Review of Chronic Lower Back Pain Clinical Studies Finds Minimally Invasive Procedure Spares Patients From Spine Surgery
- Symbollon Provides Update on IoGen Phase III Pain Study
- Positive Findings From Clinical Studies of QUADRAMET(R) in Prostate Cancer Patients With Metastatic Bone Disease Presented at ASCO Prostate Cancer Symposium
 |
 |
User Comments (0)
RSS Feeds