Cadence Announces Topline Results Of Acetavance Clinical Trial
Cadence Pharmaceuticals announced top line results of two of the company's four pivotal, Phase III clinical trials of Acetavance, a formulation of acetaminophen for intravenous use.
One of these clinical trials did not meet its primary endpoint of demonstrating a statistically significant reduction in patients' pain intensity levels over 48 hours compared to placebo, following abdominal gynecologic surgery. However, this same study successfully achieved several secondary endpoints, including pain relief, global patient satisfaction and time to rescue medication. Cadence also announced that its Phase III clinical trial of Acetavance in fever successfully met the primary endpoint, demonstrating a statistically significant reduction of fever over six hours compared to placebo.
Importantly, Acetavance demonstrated a safety profile in both of these clinical trials that was no different than placebo, including the evaluation of eight doses over a 48-hour period. The overall safety profile of Acetavance compares favorably with published safety data on oral acetaminophen, which is generally considered safer than a number of other pain medications currently used in the hospital setting.
"We are very pleased that the fever trial met its primary endpoint, that Acetavance was found to be safe and well-tolerated in both studies, and that there were strong positive results for several secondary endpoints in the pain trial," said James Breitmeyer, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Cadence. "We believe that our clinical trial in patients undergoing abdominal gynecologic surgery did not meet its primary endpoint because of substantially higher than predicted variability in pain intensity scores. We remain confident in the design of our ongoing Phase III clinical trial of Acetavance for the treatment of pain in adults following abdominal laparoscopic surgery, which commenced enrollment of patients in the fourth quarter of 2007. However, we will request a meeting with the United States Food and Drug Administration (FDA) to obtain the agency's advice regarding our development program for this product candidate."
"Based on the excellent safety results and the positive secondary endpoints in our abdominal gynecologic surgery clinical trial, we remain firmly committed to continuing the development of Acetavance in the United States for the treatment of acute pain and fever," said Ted Schroeder, President and Chief Executive Officer of Cadence. "Our confidence is also supported by other successful post-operative pain trials of intravenous acetaminophen and the product's strong position as the market leading injectable analgesic in Europe, where over 200 million doses have been sold since the product was launched there in 2002."
The abdominal gynecologic surgery trial, referred to as Study 301, was a Phase III, randomized, double-blind, placebo controlled, multi-center, multiple-dose study of the analgesic efficacy and safety of intravenous acetaminophen versus placebo over 48 hours for the treatment of post-operative pain following abdominal gynecologic surgery. Three hundred thirty-one hospitalized patients were enrolled in this study at 27 clinical sites in the United States.
The fever study, referred to as Study 302, was a Phase III, randomized, double-blind, placebo-controlled study of the antipyretic efficacy and safety of intravenous acetaminophen over a six-hour period. In this study, 60 adult patients at one United States clinical trial site received a single dose of Acetavance versus placebo.
Following its planned discussions with the FDA, Cadence will provide updated guidance if there is any change to the anticipated timing for submission of a New Drug Application for Acetavance, or if any additional clinical trials are required. The company also intends to disclose more detailed results of both Study 301 and Study 302 clinical trials in an appropriate medical or scientific setting after the completion of data analysis for the two studies.