FDA okays opioid use disorder treatment

The FDA approved a monthly injection called Sublocade to treat those addicted to opioids

The FDA approved a monthly injection called Sublocade to treat those addicted to opioids

USA health officials have approved the first injectable form of the leading medication to treat patients recovering from addiction to heroin, prescription painkillers and other opioids.

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.

The new injection has potential to reduce abuse and diversion of buprenorphine, which is itself an opioid sometimes sold on the black market. Other opioid abuse medications include methadone and naltrexone, an injection approved to treat opioid and alcohol addiction.

While studies show patients on medications like buprenorphine cut their risk of death by half, some recovery groups favor abstinence-only approaches to treatment. It is a drug-device combination product that utilizes the Atrigel Delivery System in a prefilled syringe. After initial formation of the depot, buprenorphine is released by the breakdown (biodegradation) of the depot.

Sublocade was evaluated in clinical studies involving almost 850 adults who were diagnosed with moderate-to-severe cases of the disorder.

And Johns Hopkins researchers recently reported that deaths from drug overdoses rose from about 52,000 in 2015 to more than 64,000 in 2016.

"Sublocade is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program", said the FTSE 250 company's chief executive officer, Shaun Thaxter.

The most common side effects included constipation, nausea, vomiting, headache, drowsiness, injection site pain, pruritus at the injection site, and abnormal liver function tests. FDA is now evaluating this type of labeling for naltrexone and methadone as well, he said.

The FDA granted the approval of Sublocade to Indivior Inc.

The product can only be dispensed by healthcare professionals under a risk evaluation and mitigation strategy (REMS), and it comes with a boxed warning on the risks of intravenous administration - including occlusion, tissue damage, or embolus.

Indivior's product is the first monthly injectable buprenorphine treatment.

Sublocade will be available through a restricted distribution system.

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