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AcelRx Announces Initiation Of Phase 3 Clinical Program For ARX-01, The Sufentanil NanoTab® PCA System For The Treatment Of Post-Operative Pain

REDWOOD CITY, Calif., March 6, 2012 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), ("AcelRx"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, reported dosing of the first patient in a Phase 3 study for ARX-01, the Sufentanil NanoTab PCA System, its novel sublingual patient-controlled analgesia system. This first ARX-01 Phase 3 study is a randomized, double-blind, placebo-controlled efficacy and safety trial in adults following open abdominal surgery.  Approximately 150 adults, randomized 2:1 to active or placebo groups, will be treated for post-operative pain for a minimum of 48 hours and, as needed, up to 72 hours after randomization.  The study will be conducted at 12 academic and community hospitals in the United States.

The remainder of the planned Phase 3 clinical program for ARX-01 includes a second randomized, double-blind, placebo-controlled efficacy and safety study comparing Sufentanil NanoTabs to placebo for post-operative pain control following major joint replacement surgery, and an open-label active-comparator study comparing ARX-01 to the current standard of care, intravenous patient-controlled analgesia, or IV PCA, with morphine.

"We are extremely pleased to have our ARX-01 Phase 3 clinical program underway.  This year is an exciting time for AcelRx, with the delivery of top-line data from all three Phase 3 clinical trials expected by late 2012 or early 2013," said Richard King, AcelRx's Chief Executive Officer.  Mr. King added, "We hope to be in a position to file an NDA with the FDA in mid-2013 for ARX-01.  We believe ARX-01 is highly differentiated from the current standard of care for post-operative pain management, IV PCA.  We look forward to the time when ARX-01 will be available to patients and health care providers as a non-invasive, pre-programmed, high therapeutic index opioid alternative to IV PCA."

About Post-Operative Pain

Acute pain management in the hospital, in particular post-operative analgesia, remains a challenge for healthcare providers with up to 75% of patients reporting inadequate pain relief after surgery.  Inadequate treatment of post-surgical pain can lead to decreased mobility, which increases the risks for the medical complications, including deep vein thrombosis and partial lung collapse, potentially resulting in extended hospital stays.  Over 23 million procedures per year result in moderate to severe post-operative pain in the major pharmaceutical markets (US, 5 main EU countries and Japan), resulting in $5.1 billion of acute pain treatment product sales.  Current standard of care for managing post-operative pain is IV PCA, typically utilizing morphine or hydromorphone.  However, there are many deficiencies associated with the current use of IV PCA that can negatively impact patient safety, well-being and recovery.  These include drug-related side effects associated with morphine or hydromorphone, complications associated with IV delivery, and medication delivery errors typically associated with misprogramming of the complex IV PCA pumps.

About ARX-01, the Sufentanil NanoTab PCA System

ARX-01 is a pre-programmed, non-invasive, handheld system that allows post-operative patients to self-dose with sublingual Sufentanil NanoTabs to manage their post-operative pain. The ARX-01 System is designed to address the limitations of IV PCA by offering:

  • A high therapeutic index opioid :  Because ARX-01 uses the high therapeutic index opioid Sufentanil, it offers post-operative pain patients the potential for effective patient-controlled analgesia with a low incidence of drug-related side effects.  Published data on IV PCA side-effect profiles suggests that somnolence (~50% of patients) and oxygen desaturation (~10% of patients) is unacceptably high.  In our Phase 2 clinical studies, patients dosing over 12 hours with Sufentanil NanoTabs (15 mcg) exhibited a low incidence of somnolence (3%) and oxygen desaturation (1%).
  • A non-invasive route of delivery : The sublingual route of delivery used in ARX-01 provides rapid onset of analgesia, therefore eliminating the risk of IV-related analgesic gaps and IV complications, such as catheter-related infections.  In addition, because patients are not tethered to IV tubing and a pump for pain relief, ARX-01 allows for ease of patient mobility.
  • A simple, pre-programmed PCA solution : ARX-01 is a preprogrammed PCA System designed to eliminate the risk of pump programming errors, which are a potential source of patient harm. 

 

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