Hydrocodone bitartrate ER: Phase III data
Top-line data from the double-blind, U.S. Phase III Study 3103 in about 623 patients with moderate to severe chronic low back pain showed that CEP-33237 met the primary endpoint of maintaining the improvement in weekly average of daily WPI scores that was achieved during an open-label titration period of up to 6 weeks with CEP-33237 vs. placebo. Specifically, CEP-33237 led to an increase in the weekly average of daily WPI scores from the end of the titration period to treatment week 12 of the double-blind portion of 0.07 points vs. an increase of 0.71 points for placebo (p<0.001). Patients received twice-daily 15-90 mg doses of CEP-33237 for up to 6 weeks in an open-label titration period. Responders were then randomized to receive either their identified maintenance dose of CEP-33237 or placebo for 12 weeks. All patients were offered rescue medication as needed.
CEP-33237 also met the secondary endpoint of improving weekly average daily API scores vs. placebo (p<0.001). The most common reported adverse events included gastrointestinal and CNS events. Teva said that CEP-33237 demonstrated a safety profile consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Teva said the potential abuse-deterrent properties of CEP-33237 were confirmed in previously conducted in vitro and pharmacokinetic studies, as well as a human abuse liability study. Additionally, the company said CEP-33237 has been evaluated to measure vulnerability against physical manipulations, chemical extractions and multi-step chemical extractions, as well as the "likeability" of a manipulated tablet in a clinical abuse potential study. By year end, Teva plans to submit an NDA to FDA for CEP-33237. ...