Indivior announced that the Food and Drug Administration (FDA) has approved Sublocade (buprenorphine extended-release) injection for subcutaneous (SC) use for the treatment of moderate-to-severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for ≥7 days. This approval makes Sublocade the first once-monthly injectable buprenorphine formulation for this condition.
Sublocade, a partial agonist at the mu-opioid receptor, provides sustained plasma levels of buprenorphine which blocks the drug-liking effects of opioids by taking up high receptor occupancy in the brain. It is a drug-device combination product that utilizes the Atrigel Delivery System in a prefilled syringe. It is injected as a solution and the delivery system forms a buprenorphine-containing depot that releases the drug as the depot breaks down.
In the 12-week Opioid Blockade Study (RB-US-13-0002), researchers assessed the ability of Sublocade 300mg to block the subjective effects of illicit opioids, including drug-liking. Data showed that the use of Sublocade resulted in complete blockade of drug-liking effects of hydromorphone for a full month in most patients.
In a 24-week, Phase 3 study (RB-US-13-0001), patients were randomized to 6 once-monthly Sublocade 300mg doses, 2 once-monthly Sublocade 300mg doses + 4 once-monthly 100mg doses, or 6 once-monthly injections of placebo. Both Sublocade regimens proved superior to placebo in achieving more illicit opioid-free weeks (P<0.0001). Regarding safety, Sublocade had a consistent profile with that of transmucosal buprenorphine, apart from injection site reactions; none of the reactions were deemed serious.
Sublocade is a CIII controlled substance and should be administered by a clinician as part of a complete treatment program that includes counseling and psychosocial support. It carries a boxed warning that includes the risk of intravenous (IV) self-administration that can result in occlusion, tissue damage, or embolus.
Sublocade will be available through a restricted distribution system. It is anticipated to launch in the first quarter of 2018 as 100mg/0.5mL and 300mg/1.5mL strength prefilled syringes.
For more information call (877) 782-6966 or visit Indivor.com.