FDA approves once-monthly injectable buprenorphine product

The U.S. Food and Drug Administration (FDA) this week announced it has approved a once-monthly injectable buprenorphine product for the treatment of opioid use disorder in patients who have started treatment with a sublingual film buprenorphine-containing product, such as Suboxone.

Sublocade, the once-monthly injectable, is designed for patients who have been on a stable dose of buprenorphine treatment for seven days.

Prior to its approval by the FDA, Sublocade was evaluated in two clinical studies of 848 adults with diagnoses of moderate-to-severe OUD who had begun treatment with a sublingual film buprenorphine product. Results showed patients treated with Sublocade had more weeks without positive urine tests or self-reports of opioid use, and a higher portion of patients exhibited no signs of illicit opioid use through the treatment period when compared with a placebo group.

Stuart Gitlow, MD, MPH, immediate past president of the American Society of Addiction Medicine (ASAM) board of directors, says that while having more treatment options is always better for clinicians, he has “not seen in the past in the psychiatric field that introduction of injectable alternatives has always led to any significant change in how the drugs are utilized in the marketplace.”

Gitlow cites a reduction in potential diversion of medication as one benefit of the injectable, but cautions that there are negatives to be considered as well.

“Those negatives are going to be how is the doctor going to have the drug available on hand? How will doctor store drug? How will doctor pay for drug?” Gitlow says. “What about a patient with a monthly formulation on board who gets into a situation where they need co-agonist narcotics? A car accident injury, surgery, etc. Those issues all have to be considered.

“How many of the doctors who provide buprenorphine will be appropriately trained to give this drug and are willing to take on the added liability of side effects due to an injection that they don’t have when they provide the oral form?”

Sylvester “Skip” Sviokla, MD, ABAM, is a Rhode Island-based operator of a buprenorphine treatment practice that incorporates on-site counseling services and support. Sviokla says he likes the idea of a shorter-acting injectable product, but given the heightened state of risk patients are in during the early portion of their recovery, a month-long product could give patients the wrong impression about their recovery.

“The idea of an injection making people OK, at least in the first six or seven months, is not a good idea,” Sviokla tells Addiction Professional. “It says, ‘Hey, I got a shot. I’m OK.’ It downplays in patients’ mind the need to even go to further treatment that combines medication-assisted treatment with good counseling.”

In its release announcing its approval of Sublocade, the FDA notes that the injectable should be used as part of a complete treatment program that includes counseling and psychosocial support, not as a substitute for those treatment modalities.

The FDA also said it will require future studies to assess:

• Which patients would benefit from a higher dosing regimen;
• Whether use of Sublocade can be started without an initial period of sublingual buprenorphine usage;
• The feasibility of administering Sublocade at intervals even longer than one month;
• The potential for a process to transition patients with long-term stability on a transmucosal buprenorphine dose to a monthly injectable dose without the use of a higher dose for the first two months of treatment.