Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior (p<0.001) to IV PCA morphine for the primary endpoint of PGA over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of "good" or "excellent" (78.5% vs. 66.1% respectively). The assessment of non-inferiority is based on a lower limit of -15% for the 95% confidence interval (CI) around the difference between these percentages. Because the 95% CI was +3.2% to +21.6% for the 48 hour PGA and therefore didn't cross the zero difference line, a statistical analysis for superiority could be performed, which demonstrated that for this study, the NanoTab System was statistically superior to IV PCA morphine for the PGA endpoint (p=0.009). This statistically superior PGA was also seen at the 24 hour and 72 hour timepoints. Additionally, the percentage of patients rating the NanoTab System as "Excellent" was higher than those rating IV PCA morphine as excellent (42.9% vs. 30.6%, p=0.016). Similar percentages of NanoTab System-treated and IV PCA morphine-treated patients dropped out of the study prematurely due to lack of efficacy (7.3% vs. 8.3% respectively) or due to an adverse event (7.9% vs. 11.1% respectively).Nurses setting up the different treatments for use and managing patients in the study reported that they had greater Overall Satisfaction (3.93 vs. 3.32 out of 5, p<0.001) and Overall Ease of Care (4.26 vs. 3.82, p=0.018) with the Sufentanil NanoTab PCA System compared to IV PCA morphine. Likewise, patients in the study reported that they had greater Overall Satisfaction (4.15 vs. 3.83 out of 5, p=0.003) and greater Overall Ease of Care (4.45 vs. 4.07, p<0.001) with the NanoTab System compared to IV PCA morphine. "Our goal at AcelRx has always been to improve upon the management of post-operative pain using a simplified system that nurses don't have to program," commented Pamela Palmer MD, PhD, Chief Medical Officer and AcelRx co-founder. "The validated Patient Overall Ease of Care assessment is a multi-dimensional evaluation that includes confidence, comfort and ease of movement with the delivery device, along with dosing confidence, pain control and knowledge and understanding of product use. The higher score in this composite measure, which reflects higher scores in each of the subscales, along with the higher nursing Overall Satisfaction ratings, and combined with the excellent pain control demonstrated in the PGA rating validates our efforts for developing this product for hospitalized patients" added Dr. Palmer. "It was impressive to observe the ease of set-up and use of the Sufentanil NanoTab PCA System by both nurses and patients compared to our typical IV PCA system," stated study investigator Dr. Harold Minkowitz in the Department of Anesthesiology at Memorial-Hermann Hospital in Houston, Texas. "Observing the rapid onset and significant level of pain relief obtained with this non-invasive route of opioid administration over a broad range of patients and types of surgery was remarkable." In addition to this well-controlled supportive trial, two other Phase 3 clinical studies of the Sufentanil NanoTab PCA System are underway. In March 2012, AcelRx initiated a randomized, double-blind, placebo-controlled efficacy and safety study comparing the NanoTab System to placebo for post-operative pain control following major open abdominal surgery. In August 2012, AcelRx initiated a randomized, double-blind, placebo-controlled efficacy and safety study comparing the NanoTab System to placebo in treating post-operative pain following major joint replacement surgery. Data from both of these pivotal studies are expected in the first quarter of 2013. Additional information about the Phase 3 clinical trials with the NanoTab System can be found by visiting www.clinicaltrials.gov and using the identifiers, NCT01660763, NCT01539642 and NCT01539538. 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 following surgery. Inadequate treatment of post-surgical pain can lead to decreased mobility, which increases the risks for serious medical complications, including deep vein thrombosis and partial lung collapse, potentially resulting in extended hospital stays. More than 30 million surgical procedures per year result in moderate to severe pain in the US and EU, with an additional 27 million procedures in countries with moderate to high per capita healthcare expenditures. The US, 5 main EU countries and Japan represented $5.1 billion of acute pain treatment product sales in 2008. Currently patients experiencing post-operative pain in the hospital may have IV PCA treatment, typically utilizing morphine or hydromorphone. However, there are 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 SystemARX-01 is an investigational 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 : 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.
- 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 pre-programmed PCA System designed to eliminate the risk of pump programming errors.