Teva Pharmaceutical Industries (TEVA) reports positive Phase 3 results for its hydrocodone bitartrate (CEP-33237) extended-release tablets for lower back pain.
Patients were dosed at 30mg - 90mg every 12 hours. Their degree of pain was measured by weekly average Worst Pain Intensity (WPI) and weekly Average Pain Intensity (API) scores.
The study utilized a randomized withdrawal design to evaluate the safety and efficacy of the drug. After randomization, all patients who continued to receive CEP-33237 maintained their improved WPI scores. Patients who received the placebo had significantly worse scores.
The product is acetaminophen-free and contains abuse-deterrent properties.
The company plans to submit its NDA to the FDA by the end of the year.