By Ed Coghlan
As federal scrutiny over opioid abuse continues to accelerate, news this week that an alternative is commercially available.
BioDelivery Sciences International, Inc. (BDSI) announced the commercial availability of 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™, distributed and promoted by Endo Pharmaceuticals, is now available nationwide.
“BELBUCA is particularly important since it provides an important new alternative for the millions of individuals who suffer from chronic pain,” said Dr. Mark Sirgo, CEO of BioDelivery Sciences.
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.
“BELBUCA is a very important product to BDSI, as well as to our partner Endo, who has a significant presence in pain and who is committing significant resources to support the launch of BELBUCA. We believe BELBUCA is in excellent hands and we look forward to its future growth,” said Dr. Sirgo.
The U.S. Food and Drug Administration (FDA) approval of BELBUCA 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 side effects. BELBUCA™ is available in seven dosage strengths for flexible dosing from 75 μg to 900 μg every 12 hours, allowing physicians to titrate BELBUCA™ individually for patients to a tolerable dose that provides adequate analgesia with minimal side effects.
BELBUCA™ is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilizes BDSI’s BioErodible MucoAdhesive (BEMA®) drug delivery technology. 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 oral MSE, BELBUCA™ offers a treatment choice for a wide range of opioid needs in chronic pain sufferers.