The FDA approved Sublocade, the first buprenorphine injection taken monthly for moderate-to-severe opioid use disorder in adult patients who have begun treatment with a transmucosal buprenorphine-containing product and have been on a stable dose of buprenorphine treatment for at least 7 days, according to a press release.
Sublocade (Indivior) “provides a new treatment option for patients in recovery who may value the benefits of a once-monthly injection compared to other forms of buprenorphine, such as reducing the burden of taking medication daily as prescribed,” the FDA said.
“Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan,” FDA Commissioner Scott Gottlieb, MD, said in the release.
The FDA stated that Sublocade should be used as part of a complete treatment program that includes psychosocial and counseling support, and is injected subcutaneously by a health care professional. In clinical trials, Sublocade allowed for sustained therapeutic plasma levels of buprenorphine over the 1-month dosing interval.
The safety and efficacy of Sublocade were evaluated in two clinical studies involving 848 adults younger than 65 years with a diagnosis of moderate-to-severe opioid use disorder who began treatment with buprenorphine/naloxone sublingual film, according to the FDA. When the dose was stable, patients received Sublocade by injection, then underwent urine drug screening and self-reporting of illicit opioid use during a 6-month treatment period. The agency further stated that results showed that patients who took Sublocade had more weeks without self-reports of opioid use or positive urine tests, and a higher proportion of patients had no evidence of illicit opioid use throughout the treatment period, compared with the placebo group. The safety and efficacy of Sublocade have not been established in children or adolescents aged younger than 17 years.
The FDA added that the most common side effects from treatment with Sublocade include abnormal liver function tests, pruritus, injection site pain, drowsiness, headache, vomiting, nausea and constipation, and that the product contains a boxed warning that provides important safety information, including the risks involved with intravenous self-administration.
An independent FDA advisory committee supported the approval of Sublocade at a meeting held last month, and it also been granted priority review and fast track designations, according to the release. - by Janel Miller
Disclosures: Gottlieb is FDA Commissioner.