People who are receiving medication-assisted treatment for opiate addiction now have a new option.
The U.S. Food and Drug Administration (FDA) has approved the first, once-monthly injectable buprenorphine formulation for opioid use disorder. Sublocade is expected to be available in the United States in the first quarter of 2018, the company says.
Developed by Richmond, Va.-based Invidior PLC, buprenorphine extended-release Sublocade is injected under the skin. It is intended for patients who have begun treatment with a transmucosal buprenorphine-containing product and whose dose of that drug was adjusted after initiation of treatment, and who have been receiving that adjusted dose for a minimum of seven days, the FDA says.
According to prescribing information, the recommended dose of Sublocade is two monthly initial doses of 300 mg, followed by 100 mg monthly maintenance doses. Increasing the maintenance dose to 300 mg monthly may be considered for patients for whom the benefits outweigh the risks.
Sublocade is a Schedule III controlled substance and should only be administered by a healthcare provider in conjunction with a complete treatment program that includes counseling and psychosocial support.
The FDA’s Psychopharmacologic Drugs Advisory Committee recommended approval of Sublocade in November.
“In the Opioid Blockade Study, Sublocade achieved complete blockade of drug-liking effects for a full month in most patients. Sublocade is the first and only therapy that, at steady state, delivers buprenorphine at a sustained rate of at least 2 ng/mL over a 1-month period,” Indivior CEO Shaun Thaxter said in a news release.
In the clinical trials, the overall safety profile for Sublocade was consistent with the known safety profile of transmucosal buprenorphine, except for injection site reactions, which were reported in 16.5 percent of patients. The most common adverse reactions (≥5 percent of patients) included constipation, nausea, vomiting, abnormal liver enzymes levels, headache, sedation, and somnolence.
The Sublocade label contains a boxed warning stating that “serious harm or death could result if administered intravenously.” It is only available through a restricted risk evaluation and mitigation strategy (REMS) program. Healthcare providers and pharmacies that order and dispense Sublocade must be certified and comply with the REMS requirements.
Sublocade is the third drug approved by the FDA for the treatment of opioid addiction: buprenorphine, methadone, and naltrexone. “All three of these treatments have been demonstrated to be safe and effective in combination with counseling and psychosocial support.,” said FDA Commissioner Scott Gottlieb, M.D. “Everyone who seeks treatment for an opioid use disorder should be offered access to all three options.”
Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support, the FDA says.
The safety and efficacy of Sublocade were evaluated in two clinical studies 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 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.
According to the FDA, 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 of age.
The FDA is requiring post-marketing 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, and to evaluate the feasibility of administering Sublocade at a longer inter-dose interval than once-monthly.
The FDA also wants 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.