Hydrocodone bitartrate ER: Phase III data
Top-line data from a double-blind, U.S. Phase III trial in 588 opioidnaive and opioid-experienced patients with moderate to severe chronic low back pain showed that once-daily hydrocodone bitartrate ER met the primary endpoint of reducing mean pain score as measured by an 11-point NRS over a 24-hour period recorded daily during week 12 from baseline vs. placebo (p=0.0016). Of patients treated with hydrocodone bitartrate ER, Purdue said a "majority" achieved a >=30% improvement in pain intensity and 48% achieved a 50% improvement. The most common adverse events reported by patients in the hydrocodone bitartrate ER arm were constipation, nausea, vomiting, dizziness and headache. Patients received oncedaily placebo or hydrocodone bitartrate ER at an initial dose of 20 mg, which was increased once every 3-5 days up to a dose of 120 mg if necessary until adequate pain control was achieved. Purdue plans to submit an NDA to FDA for the product this year.
According to Purdue, currently available hydrocodone formulations do not incorporate abuse-deterrent technologies. Purdue 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. ...