RESEARCH TRIANGLE PARK, N.C., July 12 /PRNewswire/ -- Xsira Pharmaceuticals, Inc. announced today that its Investigational New Drug application (IND) for intravenous adenosine was filed on June 3, 2005 with the U.S. Food and Drug Administration (FDA) and is now active. Under the IND, Xsira intends to develop adenosine as an intraoperative infusion to reduce postoperative pain following surgery. Patient enrollment into a Phase 2, multicenter clinical trial is expected to commence in the fall. Published clinical studies of adenosine in the surgical setting have been conducted under various physician-sponsored investigations in over 300 patients in the U.S. and abroad.
Pain in the immediate postoperative period remains a major clinical issue that affects the majority of the more than 50 million surgical patients each year in the U.S. Postoperative pain is frequently managed by patient- controlled analgesia (PCA) using infusion devices that deliver opioid analgesics (narcotics) as needed. However, pain relief is often limited by the development of acute tolerance, as well as opioid-related side effects, such as nausea, vomiting, constipation, urinary retention, sedation and cognitive impairment, or life-threatening complications, such as respiratory depression. Numerous preclinical studies in various animal models suggest that adenosine, a natural substance found in virtually all cells of the body, may act via peripheral and central mechanisms to impart pain relief.
Xsira has engaged the Global Perioperative Research Organization (GPRO) to manage the trial. GPRO is a strategic collaboration between the Duke Clinical Research Institute (DCRI) and the International Anesthesia Research Society (IARS). DCRI is the largest Academic Research Organization (ARO) in the world with established access to major academic research centers and thought-leading clinical investigators. The planned study (Protocol ADO-122) is a Phase 2, randomized, double-blinded, multicenter, placebo-controlled, escalating dose- response trial of intravenous adenosine for perioperative analgesia in females undergoing abdominal hysterectomy or myomectomy. The primary endpoint of this trial is to determine the dose-response profile of adenosine with respect to perioperative analgesia and opioid-sparing properties.
"This is our first IND approval and certainly an important product development milestone for Xsira," commented Dr. Roger D. Blevins, Xsira President and CEO. "Moreover, there is already a published body of evidence supporting the clinical utility of adenosine in pain management. Due to its multifaceted mechanisms of action, in addition to the ADO-122 trial in acute perioperative pain, we are considering parallel investigations into the treatment and/or prevention of chronic pain syndromes."
Published data from physician-sponsored clinical trials suggest that an intraoperative infusion of adenosine may lower postoperative pain scores and reduce postoperative narcotic consumption and related complications following surgery.
"Based on the published literature, we at GPRO are optimistic that adenosine could be a valuable addition to multimodal surgical pain treatment," commented Dr. TJ Gan, Professor of Anesthesiology at Duke University Medical Center. "There is a clear need for non-narcotic alternatives with intrinsic analgesic activity, or meaningful opioid-sparing effects"
It is noteworthy that small volume formulations of adenosine have been previously approved for other acute care indications in the U.S. and Europe. Dr. Roger D. Blevins, President and CEO of Xsira, played a pivotal role in the development of adenosine for its cardiovascular indications, co-authoring the New Drug Applications (NDAs) that were approved by the U.S. Food and Drug Administration. These small volume formulations of adenosine continue to be marketed in the U.S. and Europe.
Xsira Pharmaceuticals, Inc., headquartered in Research Triangle Park, NC, is a private biopharmaceutical company focused on the acquisition, development and commercialization of surgical and pain management drug products. The Company is also actively pursuing the licensing of related product opportunities to further provide the basis for emerging as a specialty pharmaceutical company. For more information about Xsira Pharmaceuticals, Inc., please visit the Company's website at http://www.xsira.com
Terry E. Willard
Executive Vice President
Xsira Pharmaceuticals, Inc.
7030 Kit Creek Road
Morrisville, NC 27560
Phone: 919-248-8000 ext. 8804
Xsira Pharmaceuticals, Inc.