FDA approves first once-monthly buprenorphine injection

The US Food and Drug Administration (FDA) announced it has approved Sublocade, a once-monthly buprenorphine injection for moderate to severe opioid use disorder (OUD).

Current buprenorphine-based treatments for OUD employ an oral mode of administration and require daily intake, thus posing the issue of medication adherence. These treatments are also available in the form of an implant (Probuphine), which provides stable delivery of low-dose buprenorphine over a 6-month period.

The agency's commissioner, Scott Gottlieb, MD, noted the importance of providing an array of treatment options for OUD. "Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan," he said.

Sublocade (RBP-6000) allows the sustained delivery of buprenorphine over a 1-month period, thanks to the Atrigel Delivery System, which, on subcutaneous injection, forms a solid deposit, subsequently broken down to steadily release the drug.

In a study investigating the efficacy of RBP-6000 the treatment was found to reduce "drug-liking" and demonstrated the safety and tolerability of the treatment for patients ages 17 to 65 years. Clinical studies showed that patients treated with Sublocade had fewer weeks with positive urine tests and self-reported opioid use vs patients receiving placebo.