Once-a-month opioid: Injectable Sublocade wins US approval

By Flora Southey contact

- Last updated on GMT

GettyImages/magical_light
GettyImages/magical_light
The US FDA has approved Indivior’s once-monthly, injectable buprenorphine formulation to treat moderate to severe opioid use disorder.

The Agency said Sublocade – which targets the mu-opioid receptor – is the first and only once-monthly injectable buprenorphine formulation to be authorised in the US.

“Sublocade delivers sustained plasma levels of buprenorphine that translate into high mu-opioid receptor occupancy in the brain, which blocks the drug-liking effects of opioids,” ​said Indivior in a statement.

“As a once-monthly injectable, Sublocade removes the need to patients to remember to take their medication every day, while providing them with the opportunity to focus on psychosocial support, which is an important part of their treatment programme.”

Indivior said it expects the drug – which has a wholesale acquisition cost of $1,580 (€1,333) per monthly dose – to be available to patients in the US in Q1 2018.

Delivery tech

The extended-release formulation is administered by healthcare professionals via a once-monthly subcutaneous injection in the abdominal region, using Indivior’s Atrigel delivery system.

The Atrigel delivery system is made up of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent.

Once injected, the NMP “diffuses out of the polymer matrix and the polymer precipitates, trapping the drug inside and forming an amorphous solid depot in situ,” ​said the firm.

As the polymer degrades, the depot releases the buprenorphine formulation at a sustained rate of at least 2 ng/mL over a 30-day period.

Combatting opioid use disorder

Last month, the US Food and Drug Administration (FDA) issued​ final guidance for evaluating the abuse deterrence of generic solid oral opioid drug products, to combat opioid use disorder “epidemic​.” 

Recent developments in drug delivery technology include extended-release injections, ‘unbreakable’ pills, and subcutaneous implants.

In October​, Titan Pharmaceuticals teamed with Opiant Pharmaceuticals to investigate skin implant technology, to delivery antagonists designed to target and block opioid receptors.

In the same month, Daiichi Sankyo announced​ it would commercialise an abuse-deterrent formulation of the opioid painkiller morphine sulphate in collaboration with Inspirion Delivery Sciences.

The drug uses Inspirion’s anti-abuse technology, designed to make pills resistant to cutting, crushing or breaking.

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