Opioid Treatment Receives FDA Nod

The US Food and Drug Administration (FDA) has approved Belbuca (buprenorphine) buccal film (developed by Endo Pharmaceuticals and BioDelivery Sciences) for treating chronic pain in patients for whom existing alternatives don’t work.

The agency gave its approval following data from two phase 3 studies which tested the drug’s safety and efficacy in a total of 1559 patients with moderate to severe chronic low back pain.

In both studies, using Belbuca generated a consistent, statistically significant improvement in patient-reported pain relief each week from baseline to week 12 compared with placebo.

The most common adverse reactions reported by trial participants treated with Belbuca include nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.

Placed on the inner cheek lining, Belbuca is designed to quickly deliver the analgesic drug buprenorphine directly into the blood stream.

Since buprenorphine has a lower abuse potential than other opioid medications, Belbuca film patch could also serve in preventing snorting or injecting as powder or liquid.

With the lower potential for drug misuse, physicians could write a six-month prescription rather than writing prescriptions on a month-to-month basis.

Jim Molloy, analyst at Laidlaw & Co Ltd, said, “Since most of the drug is absorbed through the cheek with little going through the digestive tract, Belbuca could potentially lead to lower constipation, a common side effect that most oral drugs are known to cause.”

Belbuca is slated to be commercially available (in seven dosage strengths) in the US by the first quarter ending in March 2016.