Teva reports data for abuse-deterrent hydrocodone

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said CEP-33237 met the primary endpoint vs. placebo in the Phase III Study 3103 to treat moderate to severe chronic low back pain. CEP-33237 is a twice daily extended-release (ER), formulation of hydrocodone bitartrate formulated with an abuse-deterrent technology. The product maintained the improvement in weekly average of daily worst pain intensity (WPI) scores achieved during an open-label titration period vs. placebo. The double-blind, U.S. trial enrolled about 623 patients with moderate to severe chronic low back pain.

Teva plans to submit an NDA to FDA for CEP-33237 by year end. The company was off $0.70 to $48.86 on Wednesday. ...