Sublocade™ Approved for Opioid Use Disorder

Sarah Randolph
Clinical Account Executive, PharmD, RPh

Recently, the U.S. Food and Drug Administration (FDA) approved Indivior’s Sublocade (buprenorphine), a subcutaneous injection for the treatment of moderate-to-severe opioid use disorder (OUD). Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. The drug is injected under the skin (subcutaneously) in the abdominal region by a health care professional. The recommended dose is 300mg per month for the first two months, followed by 100mg monthly maintenance doses. The maintenance dose can be increased to 300mg monthly if the benefits are determined to outweigh the risks. Sublocade must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the product is not distributed directly to patients.

The manufacturer, Indivior, plans on launching Sublocade 100mg/5mL and 300mg/1.5mL syringes during the first quarter of 2018; it will be available through a limited network of specialty pharmacies that includes Accredo. Pricing has not yet been released.

Several other dosage forms of buprenorphine are available, some of which have FDA indications for chronic pain, and others for substance abuse withdrawal. These include:

DRUG PRODUCT DOSAGE FORM DEA SCHEDULE APPROVED INDICATION(S):
Butrans® Topical patch C-III Chronic pain
Belbuca® Sublingual patch C-III Chronic pain
Subutex® Sublingual tablets C-III Opioid dependence
Probuphine® Implant C-III Opioid dependence
Sublocade™ Injection C-III Opioid Use Disorder

 

Complete prescribing information for Sublocade is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209819s000lbl.pdf