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ARTICLE | Clinical News

Purdue reports data for abuse-deterrent ER hydrocodone

March 13, 2014 1:02 AM UTC

Purdue Pharma L.P. (Stamford, Conn.) said its once-daily hydrocodone bitartrate ER met the primary endpoint of reducing mean pain intensity over a 24-hour period recorded daily during week 12 from baseline vs. placebo in a Phase III trial to treat moderate to severe chronic low back pain (p=0.0016). The double-blind, U.S. trial enrolled 588 opioid-naive and opioid-experienced patients. Purdue plans to submit an NDA to FDA for the product -- an extended-release (ER) hydrocodone formulated with abuse-deterrent technology -- this year.

According to Purdue, currently available hydrocodone formulations do not incorporate abuse-deterrent technologies. The company said it has conducted a series of laboratory manipulation and extraction studies, pharmacokinetic studies and clinical abuse potential studies with the product, but the company has not disclosed the data. Purdue markets the only pain drug in the U.S. with abuse-deterrent labeling, a reformulated version of OxyContin oxycodone. FDA approved the labeling last year. ...