Monthly Buprenorphine Injection Approved by FDA


Addiction Treatment Update: Monthly Buprenorphine Injection Approved by FDA

On November 30th, 2017 the U.S. Food and Drug Administration (FDA) approved the first once-monthly injectable form of the opioid blockade drug Buprenorphine (FDA, 2017).  Released under the brand name Sublocade, this extended release medication was approved for the treatment of moderate to severe opioid use disorder (Indivior PLC, 2017).


Buprenorphine is one of three FDA approved drugs being used in medication-assisted treatment (MAT), the others being naltrexone, and methadone. All three have been proven effective in blocking the euphoric effects of opioids.


MAT is intended to be utilized in combination with counseling, various forms of behavioral treatment, and psychosocial support systems. Sublocade will likely be considered as an alternative to the injectable extended release form of naltrexone, vivitrol, which has already been FDA approved for some time.


According to information released by Indivior PLC (2017), a global pharmaceutical company, Sublocade is expected to be available for prescription in the United States in the first quarter of 2018. In clinical trials Sublocade was found to achieve a complete blockade of opioid drug effects for a month in most patients studied (Indivior PLC, 2017)  . The drug is reported to deliver a sustained rate of 2 ng/mL over a 30 day period.

Due to black box warnings of serious risk if distributed directly and self-administered by patients, Sublocade is reportedly going to be distributed through a restricted system. According to reports, pharmacies and healthcare providers will be required to be certified in the Sublocade REMS program to order and distribute the drug.


Unlike naltrexone or vivitrol, which are not abusable, Sublocade contains buprenorphine, which is a schedule III controlled substance that can be abused by patients.


Hopefully, this new injectable form of the medication will decrease the likelihood of abuse, but that is not yet known. Naltrexone and vivitrol do not lead to dependency and withdrawal effects of the medication.  Buprenorphine does establish dependency and withdrawal effects when attempting to titrate off of a maintenance dose.  The extent and difficulty in titrating off of this new injectable form, Sublocade, is not yet being reported. The medication is expected to be further researched in post marketing studies that are to be required by the FDA.


The combination of psychological and behavioral therapy and FDA approved medications has been shown to be the most effective method of treating opioid use disorder while reducing the risk of potentially fatal relapse/overdose (Volkow, Frieden, Hyde and Cha, 2014).  Recent studies have shown both positive and negative implications for using naltrexone vs. buprenorphine.


One study by Tanum, Solli, Latif, et al. (2017) found extended-release naltrexone hydrochloride to be as effective as daily oral buprenorphine-naloxone in reducing the use of heroin and other opioids. Extended release naltrexone offers benefits in that it can be administered every 30 days and is non-habit forming, as compared to oral buprenorphine which must be taken daily and will eventually require detoxification if wishing to cease use once taking for maintenance.  The new extended release version will offer another alternative to illuminate the need for daily medication.


Another recent study sponsored by the National Institute on Drug Abuse (NIDA) published in The Lancet by Rotrosen, et-al (2017) found relapse rates to be similar for those prescribed extended release naltrexone vs. buprenorphine/naloxone. However, significantly fewer patients were able to successfully initiate naltrexone as compared to buprenorphine/naloxone following detoxification.


This is due to the fact that an individual must remain abstinent from all opioids for a brief period following detoxification for naltrexone to be safely introduced.  Therefore, researchers concluded that patients unable to successfully complete detoxification and abstain long enough to start naltrexone should be encouraged to begin using buprenorphine while engaging in treatment. Researchers further recommended that improved methods to transition patients to naltrexone should be employed.


At Evolutions Treatment Center we believe that both medications are effective and that careful assessment along with the examination of patient history and risk factors should be utilized to guide what medications are recommended to the individual in addiction treatment.


There are patients who can readily complete detoxification and safely become introduced to naltrexone in combination with undergoing intensive behavioral health treatment with a safe housing plan. However, some patients may require buprenorphine maintenance due to the inability to remain abstinent per history, current presentation, and/or complicated co-morbid pain establishing significantly greater risk of relapse and overdose. We will continue to monitor the research on the efficacy and safety of Sublocade as the medication hits the U.S. market.



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