Hydrocodone bitartrate ER: Clinical trial data

A human abuse liability study in non-dependent, recreational opioid users showed that crushed intranasal 45 mg CEP-33237 had significantly lower abuse potential as measured by peak at-the-moment drug liking and peak overall drug liking vs. intranasal immediate-release (IR) 45 mg hydrocodone powder (p=0.004 for both). A separate human abuse liability study in non-dependent, recreational opioid users showed that crushed oral 45 mg CEP-33237 powder had significantly lower abuse potential as measured by peak at-the-moment drug liking vs. oral IR 45 mg hydrocodone powder (p<0.001). Teva said that intact CEP-33237 had similar abuse potential vs. placebo in both studies. On Oct. 8, Teva said it began submission of a rolling NDA to FDA for the product, which the company expects to complete by year end. ...