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Positive Phase III Results Reported for BEMA Buprenorphine in Opioid-Experienced Patients With Chronic Pain

FDA meeting scheduled for July

Positive results have been reported from a pivotal phase III trial of BEMA buprenorphine (Endo Pharmaceuticals/BioDelivery Sciences) in opioid-experienced patients.

The drug is being developed for the management of pain that is severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in both patients who are opioid-naive and those who are opioid-experienced.

The study met its primary efficacy endpoint in demonstrating that BEMA buprenorphine provided significantly (P < 0.0001) improved chronic pain relief compared with placebo. Additional secondary endpoints supported the treatment’s efficacy. The most commonly reported adverse events in patients treated with buprenorphine compared with placebo were nausea (7.5% vs. 7.4%) and vomiting (5.5% vs. 2.3%).

The double-blind, randomized study evaluated the efficacy and safety of BEMA buprenorphine in the treatment of chronic lower back pain in opioid-experienced patients. A total of 511 patients who were titrated to a well-tolerated, effective dose were randomly assigned either to continue on that dose of BEMA buprenorphine or to receive placebo (BEMA film with no active drug), with treatment continuing for 12 weeks.

The study’s 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 and 10 = worst possible pain).

A pre-new drug application (NDA) meeting is scheduled with the FDA for July.

Buprenorphine is a partial mu-opioid receptor agonist and a kappa antagonist, as opposed to a full mu-opioid agonist, such as morphine. It is a schedule III controlled substance.

In January 2014, positive results were announced from a pivotal phase III study of BEMA buprenorphine in opioid-naïve subjects. The trial successfully met its primary efficacy endpoint, demonstrating significantly (P < 0.005) improved chronic pain relief compared with placebo.

Sources: Endo Pharmaceuticals; July 7, 2014; and BioDelivery Sciences; 2014.

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