Abbott’s Pain Drug Meets Phase III Endpoint

Abbott has reported new data from a Phase III study, which showed that the company’s investigational hydrocodone bitartrate and acetaminophen extended release medicine reduced pain in patients with moderate to severe chronic low back 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. Currently available short-acting HC/APAP combinations must be taken every four to six hours throughout the day.

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. The primary efficacy endpoint was measured as change in patients’ assessments of pain intensity based on a validated assessment tool, a visual analog scale, and compared to baseline.

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.