Cipher's NDA for CIP-Tramadol ER was accepted for review by the FDA and in January 2006, Cipher was advised by the FDA that its existing clinical data package met the requirements to file an NDA. The NDA contains data from six pharmacokinetic studies and five Phase III studies (three of these providing pivotal efficacy data and two providing long-term safety data). Data analysis on the trial is continuing and the final report will be provided to the FDA once it is available.
The 02.05 study enrolled 860 patients in a double-blind randomized fixed-dose trial designed to compare efficacy and safety of CIP-Tramadol ER with placebo. The primary efficacy endpoint of the study was WOMAC pain intensity. The trial was conducted over a 12-week treatment period in patients with moderate to moderately severe chronic pain from osteoarthritis of the knee or hip. Patients were randomly assigned to one of four arms, a placebo arm and three active arms consisting of a 100 mg, 200 mg, or 300 mg dose of CIP-Tramadol ER.