Indivior announced that SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use (CIII), is now available in the United States. SUBLOCADE is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days. It should be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support.
"We're committed to helping the patients, families and communities impacted by the opioid epidemic, and delivering new treatment options for moderate to severe opioid use disorder," said Richard Simkin, Chief Commercial and Strategy Officer of Indivior. "The availability of SUBLOCADE, with our comprehensive support services, marks a pivotal milestone for our company."
Medication-assisted treatments (MATs) for OUD may reduce the illicit use of opioids. These therapies can be beneficial for blocking the euphoric effects of mu-opioid receptor agonists.
The FDA approval of SUBLOCADE was based on data from a 24-week, pivotal double blind, placebo-controlled Phase 3 study (RB-US-13-0001) in which patients (n=504) who met DSM-5 criteria for moderate to severe OUD were randomized to one of three treatment regimens evaluating SUBLOCADE 300 mg, SUBLOCADE 100 mg and placebo, in combination with individualized drug counseling (IDC). Patients were randomized to SUBLOCADE injection or placebo after withdrawal symptoms were clinically controlled following treatment initiation with a transmucosal buprenorphine-containing product. Efficacy was evaluated from weeks 5 through 24 based on weekly urine drug screens combined with self-reported use of illicit opioid use. The proportion of patients achieving treatment success (defined as patients with ≥80% opioid‐free weeks) was statistically significantly higher in both groups receiving SUBLOCADE compared to the placebo group (28.4% [300 mg/100 mg], 29.1% [300 mg/300 mg], 2% [placebo]).
SUBLOCADE has a BOXED WARNING and will be distributed through a restricted distribution system, to ensure that SUBLOCADE is only administered by a healthcare provider. Serious harm or death could result if SUBLOCADE is administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. SUBLOCADE will only be available through restricted distribution under the SUBLOCADE Risk Evaluation and Mitigation Strategy (REMS) Program. Pursuant to the SUBLOCADE REMS, all healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified and establish processes and procedures to verify the medication is dispensed directly to a healthcare provider for administration by a healthcare provider and is not dispensed directly to the patient. Moreover, certified healthcare settings and pharmacies must not distribute, transfer, loan, or sell SUBLOCADE.
The systemic safety profile for SUBLOCADE, given by healthcare providers in clinical trials, was consistent with the known safety profile of transmucosal buprenorphine, except for injection site reactions. Common adverse reactions (≥5% patients) included constipation, nausea, vomiting, abnormal liver enzymes, headache, sedation, somnolence and fatigue. Injection site reactions were reported in 16.5% of the patients. None of the injection site reactions were serious and one led to study treatment discontinuation.