New data have supported the safety and tolerability of Belbuca (buprenorphine) buccal film (Endo Pharmaceuticals) for the long-term management of chronic pain in patients requiring around-the-clock opioids. The findings will be presented at the International Conference on Opioids (ICOO 2016) in Boston, which takes place on June 5–7.
Belbuca is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that uses patented BioErodible MucoAdhesive (BEMA) drug delivery technology developed by BioDelivery Sciences International, Inc. It is the only buprenorphine formulation developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. The product is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Buprenorphine is a schedule III controlled substance, meaning that it has been defined as having a lower abuse potential than that of schedule II drugs, a category that includes most opioid analgesics.
In the phase 3, open-label study, many patients receiving treatment with Belbuca twice daily reported a low incidence of typical opioid-like adverse events, such as nausea and vomiting, during treatment titration and for up to 48 weeks of daily therapy. The study also found that Belbuca was effective during long-term treatment and provided sustained pain relief throughout the treatment phase (48 weeks), as measured on the numeric rating scale.
The study enrolled 506 patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid treatment. The patients underwent a dose-titration period of up to six weeks followed by a long-term treatment phase (48 weeks). A total of 435 patients went on to receive long-term treatment with Belbuca 300 mcg (n = 52), 450 mcg (n = 45), 600 mcg (n = 141), 750 mcg (n = 62), or 900 mcg (n = 135) administered every 12 hours. The study’s primary objective was to determine the long-term safety and tolerability of Belbuca (dosed every 12 hours); the secondary objective was to determine the long-term efficacy of Belbuca (dosed every 12 hours).
In the safety analysis, adverse events occurred in 43% and 54% of patients during the titration (n = 506) and long-term treatment (n = 435) phases, respectively. The most common adverse events included nausea (10%), constipation (6%), and headache (4%) during the titration phase, and nausea (8%), vomiting (5%), and upper respiratory tract infection (5%) during long-term treatment.
For the efficacy endpoint, the average daily pain-intensity score during the treatment phase was between 2.9 and 3.1 on a scale of 0 (no pain) to 10 (worst pain imaginable). In addition, the need for rescue medication to relieve breakthrough pain decreased from an average of 3.0 tablets in the titration phase to 1.1 tablets in the long-term treatment phase.
Belbuca was approved by the FDA in October 2015 for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The FDA’s decision was based on data from two placebo-controlled, randomized phase 3 studies showing that Belbuca provided significant improvement in patient-reported pain relief with a low incidence of typical opioid-like adverse events.
Most patients with chronic pain are treated with daily opioid doses of 160 mg of oral morphine sulfate equivalent (MSE) or less. Belbuca is available in seven dosage strengths for flexible dosing from 75 mcg to 900 mcg every 12 hours, allowing physicians to titrate the treatment to a tolerable dose that provides adequate analgesia with minimal adverse effects.
Source: Endo Pharmaceuticals; June 3, 2016.