FDA approval for Belbuca buccal film for chronic pain management

The US Food and Drug Administration has approved Belbuca (buprenorphine) buccal film, from Endo International (Nasdaq: ENDP) and BioDelivery Sciences International (Nasdaq: BDSI), for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Belbuca, which is the first and only buprenorphine developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management, is expected to be commercially available in the USA during the first quarter of 2016 in seven dosage strengths, allowing for flexible dosing ranging from 75 micrograms to 900 micrograms every 12 hours. This enables physicians to individualize titration and treatment based on the optimally effective and tolerable dose for each patient.

Belbuca's market analysis and forecast