Indivior gets green light for monthly opioid-addiction treatment

Indivior gets green light for monthly opioid-addiction treatment

A man prepares heroin he bought on the street to be injected at the Insite safe injection clinic in Vancouver, British Columbia, Canada, on May 11, 2011.

The US Food and Drug Administration has approved what Indivior has branded Sublocate, an extended-release form of buprenorphine, meaning it is expected to be available to patients in the US in the first quarter of 2018.

The FDA has approved a once-monthly injectable depot formulation of buprenorphine (Sublocade) for mild-to-severe opioid use disorder patients who've been on the sublingual formulation for at least a week, the agency announced.

The monthly injection has the potential to reduce unsafe relapses that occur when patients stop taking their daily medication.

During an FDA advisory committee hearing last month, panelists backed the product's approval, but some raised concern about a lack of evidence for benefit with a high-dose regimen (300 mg for the initial dose and 300 mg for maintenance).

The approval comes amid the deadliest drug epidemic in USA history and a longstanding gap in medication-based treatment for patients recovering from addiction to opioids, including painkillers like OxyContin and illegal narcotics like heroin and fentanyl.

More than 64,000 Americans died past year from overdosing on opioids, which include both legal and illegal drugs such as heroin, fentanyl and OxyContin, according to the National Institute on Drug Abuse.

The new injection has potential to reduce abuse and diversion of buprenorphine, which is itself an opioid sometimes sold on the black market.

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. Indivior's Suboxone is the most widely used drug, though access has always been limited by gaps in insurance coverage, caps on prescriptions and training requirements for would-be prescribers.

Approving new buprenorphine products is part of the the FDA's effort to destigmatize drugs to treat opioid addiction.

Sublocade was studied in patients who first began treatment with a buprenorphine film dissolved under the tongue and the amount they took was considered to be stable.

"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", FDA Commissioner Scott Gottlieb said a statement late Thursday.

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