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FDA approves first monthly injection for opioid use disorder

December 04, 2017

The U.S. Food and Drug Administration (FDA) has approved Sublocade, the first monthly injectable buprenorphine product for the treatment of opioid use disorder in adult patients. It is indicated for patients that have been on a stable dose of transmucosal (absorbed through mucus membrane)  buprenorphine treatment for a minimum of seven days.


Medication-assisted treatment (MAT) for opioid addiction is an important tool that has the potential to help millions of Americans with an opioid use disorder. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. Improving access to prevention, treatment and recovery services, including the full range of MAT, is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis.


The safety and efficacy of Sublocade were evaluated in two clinical studies (one randomized controlled clinical trial and one open-label clinical trial) of 848 adults with a diagnosis of moderate-to-severe opioid use disorder who began treatment with buprenorphine/naloxone sublingual film (absorbed under the tongue). Once the dose was determined stable, patients were given Sublocade by injection. A response to MAT was measured by urine drug screening and self-reporting of illicit opioid use during the six-month treatment period. Results indicated that Sublocade-treated patients had more weeks without positive urine tests or self-reports of opioid use, and a higher proportion of patients had no evidence of illicit opioid use throughout the treatment period, compared to the placebo group.


The FDA is requiring postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer inter-dose interval than once a month, and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first two months of treatment (loading dose).


Check out CMA'ssafe-prescribing resources.


There you will find:



  • Resources on prescribing controlled substances safely and effectively to relieve pain, while simultaneously reducing the risk of prescription medication misuse, addiction and overdose.

  • California Medical Association (CMA) white papers on prescribing opioids

  • Links to relevant documents in CMA’s health law library

  • Continuing medical education courses and webinars

  • Current information on the state's prescription drug monitoring database

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