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May 05, 2014
 |  BC Week In Review  |  Clinical News  |  Clinical Results

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.


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