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, today reported additional clinical results for its lead product candidate, the Sufentanil NanoTab PCA System for the treatment of moderate-to-severe acute pain in the hospital setting. These data are being presented in five posters at the American Society of Regional Anesthesia and Pain Medicine (ASRA) spring meeting held May 2 to May 5, 2013 in Boston, MA. New analyses from the Phase 3 comparison trial of the NanoTab System to intravenous patient-controlled analgesia (IV PCA) with morphine (see press release dated November 15, 2012) demonstrate that sufentanil delivered via the NanoTab System has a significantly greater pain intensity reduction in the first four hours after starting treatment than IV PCA morphine (p<0.01). In addition, there were fewer patients throughout the study that experienced oxygen desaturation events below 95% in the Sufentanil NanoTab PCA System group than in the IV PCA morphine groups respiratory function and can be affected negatively by opioids. A decrease in oxygen saturation can be linked to the serious adverse event of respiratory depression.
"Obtaining effective control over post-operative pain early on is critical not only for patient satisfaction, but to avoid the deleterious effects of under-treatment of pain, such as pulmonary complications and an increased stress response" remarked Marc Huntoon , MD, Professor and Chief, Division of Pain Medicine at Vanderbilt University in Nashville TN. "Providing rapid, effective analgesia following major surgery while reducing oxygen desaturation events is an important advance in treatment of post-operative pain," added Dr. Huntoon.
Four additional posters presented at the meeting highlighted recently released results from a placebo-controlled Phase 3 study conducted in abdominal surgery patients, new pharmacokinetic data from a study evaluating different oral-transmucosal routes of delivery of sufentanil NanoTabs, design features for the NanoTab System, and new data from three Human Factors studies describing ease of set-up and use of the NanoTab System for patients and healthcare personnel.
"We have significant data to present at meetings during the next year based on the ongoing analysis of our recent clinical trials," stated Dr. Mike Royal , chief, clinical affairs for AcelRx. "The well-published high therapeutic index for sufentanil and its short brain equilibration time is being reinforced by the clinical data that we are collecting," added Dr. Royal.
"We are excited to present this additional data at the ASRA meeting regarding our NanoTab System. We are particularly pleased by the rapid reduction in pain intensity after treatment is started, and the reduced number of patients experiencing oxygen desaturation events, an important safety measure, when using the NanoTab System," stated Richard King , president and CEO of AcelRx. "We remain on track to submit an NDA for the NanoTab System later this year."
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