Pain management has taken a huge step forward as Belbuca, the new medication developed by BioDelivery Sciences International and Endo Pharmaceuticals has been approved by the U.S. Food and Drug Administration.
The highly anticipated approval of Belbuca was the trigger for a $50 million milestone payment to BioDelivery from Endo Pharmaceuticals, a subsidiary of Endo International.
“The FDA approval of Belbuca is a major milestone for BDSI and a tribute to the exceptional working relationship between the teams at Endo and BDSI,” said Dr. , President and Chief Executive Officer of BDSI.
The drug received its FDA approval for patients with chronic pain that is so severe that it requires around the clock, long-term opioid treatment. With its approval, Belbuca opens the way for a reliable treatment option for patients who are constantly battling chronic pain in their daily lives and, until now, have not really had a long-term viable solution for this issue.
“Belbuca will provide a novel, alternative treatment option for millions of people suffering with chronic pain,” said Dr. Andrew Finn, Executive Vice President of Product Development at BDSI.
“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.”
Endo, based in Dublin, Ireland, with its U.S. headquarters in Malvern, signed the worldwide license and development agreement with BioDelivery Sciences International in 2012, while the drug was still in phase-III trials. BDSI expects Belbuca to be commercially available nationally as soon as the first quarter of next year.
