Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced positive results from a pivotal Phase III study of hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties (CEP-33237). The results showed significant improvement in the treatment of patients’ chronic low back pain as measured by both weekly average Worst Pain Intensity (WPI) and weekly Average Pain Intensity (API) scores. CEP-33237 is an investigational twice-daily, acetaminophen-free hydrocodone formulation in development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Study 3103 utilized a randomized, double-blind, placebo controlled randomized-withdrawal design to evaluate the efficacy and safety of an abuse-deterrent formulation of extended-release hydrocodone bitartrate at doses ranging from 30mg to 90mg every 12 hours. All patients (both placebo and active arms) 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 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,
<0.001). Significant improvement in patients’ pain scores for the weekly API was also achieved (
<0.001) when an analysis was performed in patients randomized to continue receiving CEP-33237 in comparison to those randomized to receive placebo.
“There’s a significant need for an acetaminophen-free, extended-release hydrocodone formulation with potential abuse-deterrent properties,” said clinical investigator Martin Hale, M.D., medical director of Gold Coast Research, L.L.C. “While no technology can completely eliminate abuse, this abuse-deterrent formulation of hydrocodone is a potential positive step in the right direction.”