FDA approves Belbuca (buprenorphine buccal film) to treat chronic pain- Endo Pharma + Biodelivery Sciences

Endo Pharmaceuticals and BioDelivery Sciences announced that the FDA has approved Belbuca (buprenorphine) buccal film 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 US 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 dosing range enables physicians to individualise titration and treatment based on the optimally effective and tolerable dose for each patient.

Belbuca is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilises BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology. Through this unique delivery system, buprenorphine is efficiently and conveniently delivered across the buccal mucosa (inside lining of the cheek). Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics. Among chronic pain patients taking opioids, the vast majority are on daily doses of 160 mg of oral morphine sulfate equivalent (MSE) or less. With seven dosage strengths up to 160 mg MSE, Belbuca offers a treatment choice for a wide range of opioid needs in chronic pain sufferers.

Comment: The drug is indicated for severe chronic pain only among patients for whom non-opioid treatments and immediate-release painkillers are intolerable or ineffective. It carries a black-box warning describing its potential for abuse and addiction plus risks of fatal respiratory failure. However its novel delivery could help it stand out among the oral therapies now dominating the pain market.