The first buccal film formulation of buprenorphine and naloxone (Bunavail) is anticipated to reach retail pharmacies by the end of this week, offering a new treatment option to the more than 2.5 million opioid-dependent patients in the United States.
The FDA originally approved Bunavail in June 2014 for the maintenance treatment of opioid addiction as part of a complete treatment plan that includes counseling and psychosocial support. Just 5 months later, on November 3, 2014, BioDelivery Sciences International, Inc (BDSI) announced that the formulation has been shipped to wholesalers and is now commercially available.
In that announcement, BDSI President and CEO Dr. Mark A. Sirgo said Bunavail’s commercial introduction “represents a valuable addition to currently available treatment options for the appropriate patients and their health care professionals.”
Bunavail is the first and only buprenorphine and naloxone film formulation to stick to the inside of the cheek, allowing patients to talk, swallow, and conduct their normal daily activities while it is being absorbed. As such, Bunavail is in direct competition with the sublingual buprenorphine and naloxone formulation known as Suboxone.
In a phase 3 clinical study that assessed 249 patients who were converted from Suboxone to Bunavail, the latter film formulation demonstrated favorable safety and efficacy in the maintenance treatment of opioid dependence. Additionally, roughly 40% of those patients were experiencing constipation while receiving Suboxone, and more than two-thirds of them said their symptoms resolved after they switched to Bunavail.
“Opioid addiction is a serious issue that can often be difficult to treat,” said Tim Lepak, president of the National Alliance of Advocates for Buprenorphine Treatment, in a previous press release. “It is important that patients have treatment options that are effective, safe, and easy to use in order to provide them with their best chance for success. I believe people addicted to prescription opioids and heroin will welcome Bunavail as a novel treatment option.”