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FDA approves first once-monthly medication-assisted treatment option for opioid use disorder

by
Optum Workers' Comp
| Dec 04, 2017

The U.S. Food and Drug Administration (FDA) has approved Sublocade™, the first once-monthly injectable buprenorphine product in an ongoing effort to encourage safe adoption and more widespread use of FDA-approved treatments to help those afflicted by opioid addiction. Sublocade is indicated to treat moderate-to-severe opioid use disorder (OUD) in adults who have already started treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It should only be initiated after patients have been on a stable dose of buprenorphine treatment for a minimum of seven days.

Current buprenorphine treatments, to manage OUD, include administration of an oral tablet or film (dissolved in the mouth) which must be taken daily or an intradermal implant (inserted under the skin). The once-a-month Sublocade injection offers patients a new treatment option which may increase medication adherence by reducing the burden of taking a daily medication or undergoing the implant procedure.

Sublocade should be used as part of a complete treatment program including counseling and psychosocial support. It is designed to be injected subcutaneously (under the skin) by a trained health care professional and will provide buprenorphine at sustained therapeutic levels. Additionally, Sublocade must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS). As part of this requirement, pharmacies and health care providers, planning on carrying this product, must complete an enrollment form attesting to established procedures to ensure Sublocade is dispensed only to health care professionals and not directly to patients. At this point in time, it does not appear this medication will be dispensed directly to patients.

Over the coming months, monitoring of outpatient and physician office visit invoices would be prudent to track and trend the use of this medication. As with any new drug release, our team of analysts will monitor for utilization of this medication in our book of business and report on any identified trends.

Sublocade will be marketed by Indivior Inc., makers of other buprenorphine products Suboxone® and Subutex®. The product is expected to be available in the first quarter 2018. For more information, please read the FDA notice as listed in the sources below.



Sources

 

  1. U.S. Food and Drug Administration. FDA News Release. FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder. November 30, 2017. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587312.htm?utm_campaign=11302017_PR_FDA%20approves%20bunep
  2. Indivior Inc. FDA Approves SUBLOCADE™ (Buprenorphine Extended-Release), the First and Only Once-Monthly Injectable Buprenorphine Formulation to Treat Moderate to Severe Opioid Use Disorder. November 30, 2017. Available at http://www.indivior.com/investor-news/fda-approves-sublocade-buprenorphine-extended-release-first-monthly-injectable-buprenorphine-formulation-treat-moderate-severe-opioid-use-disorder/




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