Cadence loses 46% as Acetavance fails Ph III

Shares in the USA's Cadence Pharmaceuticals plummetted 46.4% to $7.50 on January 10, on news that its intravenous acetaminophen formulation, Acetavance, missed its primary endpoint in a Phase III trial. One of two pivotal late-stage studies did not demonstrate a statistically-significant reduction in patients' pain intensity levels over 48 hours compared to placebo following abdominal gynecologic surgery.

James Breitmeyer, chief medical officer of the San Diego-based drug developer, said: "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, he noted that the firm will arrange a meeting to obtain the US Food and Drug Administration's advice regarding the development program for the agent.