The FDA has approved a new option for treating chronic pain.
BioDelivery Sciences International, Inc. (BDSI) and its partner Endo Pharmaceuticals Inc. (Endo), a subsidiary of Endo International plc (ENDP) (ENL.TO), announced the U.S. Food and Drug Administration (FDA) approved BELBUCA™ (CIII) (buprenorphine HCl) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
“There is a need for alternative therapies, especially as half of the chronic pain sufferers using opioids do not feel they get consistent pain relief,” said Heather Zoumas Lubeski, Senior Director of Corporate Affairs at Endo. “BELBUCA™ presents a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility.”
Chronic pain affects more than 100 million Americans – more than diabetes, heart disease and cancer combined – with one in three experiencing persistent pain. Annually, the U.S. chronic pain market is approximately $13 billion with the majority of sales and prescriptions (130 million scripts) for opioids.
BELBUCA will be available in early 2016. Its lower abuse potential is being touted by both companies.
“BELBUCA will provide a novel, alternative treatment option for millions of people suffering with chronic pain. Clinical trials demonstrated that twice daily administration of BELBUCA was well tolerated and controlled moderate to severe chronic pain. BELBUCA will also provide healthcare practitioners and their patients with a new buprenorphine treatment option. 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,” stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI.
The product is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, those with known or suspected gastrointestinal obstruction (including paralytic ileus), and hypersensitivity (anaphylaxis) to buprenorphine.
Image courtesy of BioDelivery Sciences.