Cadence Announces Positive Phase III Results of Intravenous Drug
Posted on: Friday, 11 January 2008, 12:01 CST
Cadence Pharmaceuticals has announced positive 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's 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.
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 US.
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 US clinical trial site received a single dose of Acetavance versus placebo.
Ted Schroeder, president and CEO of Cadence, said: "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 US for the treatment of acute pain and fever."
Source: Datamonitor
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