New Phase III study data showed that Abbott's investigational hydrocodone bitartrate and acetaminophen (HC/APAP) extended release medicine reduced pain in patients with moderate to severe chronic low back pain, one of the most common causes of chronic pain.

Taken twice daily in the clinical trial, Vicodin CR™ (HC/APAP extended release) significantly lowered chronic low back pain intensity with 12-hour dosing versus placebo.

According to the American Pain Foundation, One in four American adults suffer chronic and acute pain, with lower back pain and headache as the most common types of pain.  

Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. says, Immediate-release hydrocodone with acetaminophen has four to six hour dosing and is the most prescribed medication in pain care today.  "These new extended-release data are encouraging because they showed that 12-hour dosing provided pain relief in patients with moderate to severe chronic low back pain."

The efficacy of HC/APAP extended release was assessed in patients with moderate to severe chronic low back pain in a multi-center, double-blind, placebo-controlled, withdrawal-design trial of 773 patients.

HC/APAP extended release met the primary and secondary efficacy endpoints compared to placebo. The mean change from baseline chronic low back pain intensity was significantly lower in patients receiving either one or two tablets taken twice daily of HC/APAP extended release compared to those taking placebo (8.6, two tablet, p=0.001; 13.3, one tablet, p=0.002 versus 22.2, placebo). An assessment of the multiple secondary efficacy endpoints was supportive of the primary findings. With 12-hour dosing, the pain was reduced during the 12-week treatment period.