Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients, has been approved by the U.S. Food and Drug Administration (FDA). Approval has been granted to the pharmaceutical firm Indivior to manufacture this product. It is indicated for patients who have been on a stable dose of transmucosal/sublingual buprenorphine treatment for a minimum of 7 days. Buprenorphine for the treatment of OUD is currently approved to administer as a tablet or film that dissolves in the mouth or as an implant. Sublocade provides a new treatment option for patients in recovery who may prefer the benefits of a once-monthly injection compared with other forms of buprenorphine, such as reducing the burden of remembering to take their medication daily as prescribed (medical adherence; FDA, 2017). The U.S. Department of Health and Human Services' (n.d.) Five-Point Strategy to Combat the Opioid Crisis focuses on improving access to prevention, treatment, and recovery services, including the full range of medication-assisted treatments (MATs). MAT is a comprehensive approach that combines approved medications (currently, methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with OUD. Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration (n.d.), patients receiving MAT for their OUD cut their risk of death from all causes in half.

Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. Sublocade is a drug-device combination product that utilizes buprenorphine mixed in a specific delivery system in a prefilled syringe. There is a 300-mg loading dose given on the first and second months, followed by 100-mg injections. It is injected by a health care professional (HCP) under the skin (subcutaneously) as a solution, and the delivery system forms a solid deposit, or depot, containing buprenorphine. The injection should be administered in the abdominal area. After initial formation of the depot, buprenorphine is released by the breakdown (biodegradation) of the depot. In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the 1-month dosing interval (Indivior, n.d.). 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 OUD 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 6-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 with the placebo group. The most common side effects from treatment with Sublocade include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site, and abnormal liver function tests. The safety and efficacy of Sublocade have not been established in children or adolescents less than 17 years old, and clinical studies of Sublocade did not include participants over the age of 65 years.

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 interdose interval than once-monthly, 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 2 months of treatment (loading dose). Sublocade has a boxed warning that provides important safety information, including the risks of intravenous self-administration. If the product were to be administered intravenously rather than subcutaneously, the solid mass could cause occlusion (blockage), tissue damage, or embolus (solid material that is carried in the blood and can become lodged in a blood vessel, which can lead to death). Sublocade will be provided to HCPs through a restricted program, administered only by HCPs in a health care setting, and will require health care settings and pharmacies that dispense Sublocade to complete an enrollment form attesting that they have procedures in place to ensure that Sublocade is dispensed only to HCPs and not directly to patients. The anticipated wholesale cost for this medication is $1,580 per injection. The cost for the 300- and 100-mg products is the same.

Currently, the National Institutes of Health, within the National Institute on Drug Abuse Clinical Trials Network, is conducting studies comparing the effectiveness of the two pharmacologically distinct medications used to treat OUD-a buprenorphine/naloxone combination and the extended-release naltrexone formulation. Initial outcomes have shown similar outcomes once medication treatment is initiated. Hopefully, we will see the development of algorithms to distinguish specific epidemiological and genetic markers determining which medication should be initiated.

The FDA plans to issue guidance to expedite the development of new addiction treatment options and continue to pursue efforts to promote more widespread use of existing, safe and effective therapies to treat addiction. Given the scale of the opioid crisis, all HCPs-and most specifically all nurses-should be committed to expanding access to treatments that can help people pursue lives of sobriety.

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