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Positive Results Reported From Phase III Trial of BEMA Buprenorphine in Opioid-Naïve Patients With Chronic Pain

Pain relief significantly improved versus placebo (January 23)

Positive results have been reported from a pivotal phase III efficacy study of BEMA buprenorphine (Endo Pharmaceuticals) in opioid-naïve subjects.

The drug is being developed for the treatment of moderate-to-severe chronic pain in both opioid-naïve and opioid-experienced patients who require around-the-clock opioid therapy for an extended period.

The study met its primary efficacy endpoint in demonstrating that treatment with BEMA buprenorphine resulted in significantly (P < 0.005) improved chronic pain relief compared with placebo. The most commonly reported adverse events in patients treated with buprenorphine compared with placebo were nausea (10% vs. 8%), vomiting (4% vs. 2%), and constipation (4% vs. 2%).

The phase III trial was a double-blind, randomized withdrawal study to evaluate the efficacy and safety of BEMA buprenorphine in the treatment of chronic lower-back pain in opioid-naïve patients. A total of 462 patients who were titrated to a well-tolerated, effective dose were randomly assigned to either continue on that dose of BEMA buprenorphine or receive placebo (BEMA film with no active drug), with treatment continuing for 12 weeks.

The primary efficacy endpoint was the mean change in the daily average pain numerical rating scale (NRS-Pain) scores from baseline (just prior to randomization) to week 12 of the double-blind treatment period. Pain was self-reported daily on an 11-point numeric rating scale (daily NRS; 0 = no pain, 10 = worst possible pain).

A second phase III clinical study of BEMA buprenorphine in opioid-experienced patients is ongoing.

Source: Endo Pharmaceuticals; January 23, 2014.

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