Endo announced new Phase 3 data supporting the safety and tolerability of Belbuca (buprenorphine) buccal film for the long-term management of chronic pain in patients requiring around-the-clock opioids.
The Phase 3 open-label study (n=506) enrolled patients with moderate to severe chronic pain requiring around-the-clock opioid treatment who were titrated up to 6 weeks followed by a long-term treatment phase (48 weeks). Of these patients, 435 received long-term treatment (<48 weeks) with Belbuca 300mcg (n=52), 450mcg (n=45), 600mcg (n=141), 750mcg (n=62) or 900mcg (n=135) administered every 12 hours.
The data demonstrated that patients receiving Belbuca twice daily had a low incidence of typical opioid-like adverse effects (eg, nausea, vomiting) during treatment titration and for up to 48 weeks of daily therapy. Adverse events occurred in 43.1% during the titration phase and 54.0% during the long-term treatment phase.
Belbuca also proved effective during long-term treatment and had sustained pain relief throughout the treatment phase (48 weeks) as measured on the numeric rating scale. The need for rescue medication for breakthrough pain decreased from 3 tablets during titration to 1 tablet during the long-term treatment phase.
Belbuca, a mu-opioid receptor partial agonist, is the first buprenorphine formulation designed with a dissolving film. It is available as 75mcg, 150mcg, 300mcg, 450mcg, 600mcg, 750mcg, and 900mcg strength buccal films in a peppermint flavor.
For more information call (800) 462-3636 or visit Belbuca.com.