Once-Monthly Injectable Buprenorphine: Sublocade Approved by FDA

Yesterday November 30, 2017, the US Food and Drug Administration (FDA) approved a new formulation of buprenorphine, allowing patients to visit their provider once a month for an injection to treat opioid use disorder (OUD). Indivior, the pharmaceutical company that produces and sells Suboxone, will now be marketing Sublocade, the once-monthly injectable form of buprenorphine. Indivior, on their website, indicates that Sublocade will be available in the first quarter of 2018.

  • Who is a good candidate? According the FDA, Sublocade is indicated for adult patients diagnosed with moderate-severe OUD and have been on a stable sublingual dose of buprenorphine for at least seven days.
  • How does it work?  Sublocade is injected under the skin, and  according to the FDA "the delivery system forms a solid deposit, or depot, containing buprenorphine. After initial formation of the depot, buprenorphine is released by the breakdown (biodegradation) of the depot."
  • Pricing: Indivior reports that the wholesale acquisition cost (WAC) price of Sublocade will be $1,580/month, regardless of dose. The monthly retail cost of Suboxone varies from $300-800/month, making Sublocade substantially more expensive than traditional sublingual applications.
  • Insurance coverage: Presumably Indivior has been negotiating behind the scenes with insurance companies to ensure coverage. So far, no announcements on when or whether it will be covered in Maryland.
  • Dosing: There are two doses of Sublocade, 100mg and 300mg. In Indivior's Sublocade Fact Sheet, it is a little hard to map current sublingual dosing to the new injectable doses. It reads, to us, as if the two doses would best match against 12mg and 24mg daily sublingual doses.
  • Availability:  It's still too early to tell when Sublocade will be available to MATClinics' patients.

As more information comes out, we will keep you posted.