Hydrocodone Extended-Release Tabs Effective in Pain Trial
Teva announced positive results from Study 3103, a Phase 3 study with hydrocodone bitartrate extended release tablets (CEP-33237) for moderate to severe chronic low back pain. The extended-release tablets were designed using Teva's proprietary technology, which provides potential abuse-deterrent properties.
Study 3103 was a randomized, double-blind, placebo controlled randomized-withdrawal trial designed to evaluate the efficacy and safety of an abuse-deterrent formulation of extended-release hydrocodone bitartrate at doses ranging from 30–90mg every 12 hours. All patients were administered CEP-33237 in an open label phase to identify the maintenance dose that provided adequate analgesia with acceptable tolerability. Responders were then randomized to receive either placebo or their identified maintenance hydrocodone dose. The trial measured the changes in patients' weekly average Worst Pain Intensity (WPI) between randomization and week 12 of treatment.
After randomization, patients who continued receiving CEP-33237 maintained their improved WPI score whereas patients who were randomized to receive placebo had a significant worsening of their WPI compared to baseline (0.07 for CEP-3327 vs. 0.71 for placebo, p<0.001). Significant improvement in patients' pain scores for the weekly Average Pain Intensity (API) was also achieved (p<0.001) in patients randomized to continue receiving CEP-33237 vs. placebo.
Teva plans to submit a New Drug Application (NDA) for CEP-33237 to the FDA by the end of 2014.
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