Regulatory Affairs

Indivior's Sublocade secures FDA approval to treat opioid use disorder

PBR Staff Writer Published 01 December 2017

Indivior’s Sublocade (buprenorphine extended- release) injection has been approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD).

Sublocade’s approval is for patients who had started treatment with a transmucosal buprenorphine-containing product and have been on a stable dose of the treatment for at least seven days.

The drug has been indicated to be given subcutaneously, once in a month.

The FDA advises patients that Sublocade is part of a complete treatment program and has to be taken along with counseling and psychosocial support.

FDA Commissioner Scott Gottlieb said: “Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety.

“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.”

Sublocade utilizes buprenorphine, which is a partial agonist that binds to and activates the mu-opioid receptor to moderate the subjective effects of opioids such as liking for opiod drugs and the pleasure obtained from their consumption.

According to Indivior, Sublocade releases sustained plasma levels of buprenorphine that convert into high mu-opioid receptor occupancy in the brain, thereby preventing the drug-liking effects of opioids.

Sublocade’s safety and efficacy were established in the Opioid Blockade Study and a 24-week phase 3 pivotal study. The two trials featured 848 adults in total who had moderate-to-severe OUD and had started treatment with buprenorphine/naloxone sublingual film.

Indivior CEO Shaun Thaxter said: “SUBLOCADE is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program.

“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 one month period.”

Indivior plans to launch Sublocade in the US in the first quarter of 2018.

Image: Indivior’s Sublocade 100mg. Photo: courtesy of Indivior PLC.