US pharmaceutical company Indivior has confirmed that the marketing and sale of the long-acting injectable prescription opioid Sublocade will end in Australia from 31 December 2025, describing it as a “commercial decision”. The move has caused alarm among doctors and pharmacists who consider the drug life-saving for people with opioid dependency.
Background and impact
Sublocade was added to the Pharmaceutical Benefits Scheme (PBS) in 2020 and is considered a significant advance in treatment for opioid dependency because other treatments, such as methadone and buprenorphine, require daily or frequent pharmacy visits. Sublocade is a monthly injection administered at a pharmacy or GP clinic. While an alternative monthly injection called Buvidal is available through the PBS, Melbourne GP Dr Owen Harris said “in my experience, and in the experience of many others, the Sublocade product is just much better for some people”. He added: “It’s more stable, it lasts longer, people feel better on it, and it really has been life-changing for them. Some people can stretch their dose out to once every six weeks, or even longer. It, quite honestly, has been life-saving and life-changing for many of my patients.”
Broader trend of drug withdrawals
The withdrawal comes less than a month after AstraZeneca said it would remove the breast cancer and endometriosis medicine Zoladex (a monthly 3.6mg implant) from the PBS and private market, also citing lack of commercial viability. Federal Health Minister Mark Butler said last month that drug pricing is in an “enormous state of flux” amid US policy changes. He noted that policies such as the US “most favoured nations” approach “are reshaping how companies think about pricing”. Critics say pharmaceutical companies will not compromise their profits in the US and may raise prices in smaller markets or pull out altogether if higher prices are not agreed to by governments.
Concerns from health professionals
Pharmacist Angelo Pricolo, who became the first person in Australia to administer Buvidal in 2020, described both Buvidal and Sublocade as particularly important for those living in remote areas. He said there are “significant differences” between the two drugs “that mean some patients respond better to one over the other”. He noted: “We sometimes see those requiring higher doses do better with Sublocade and also the duration of action importantly can be different. Choice for the patient and healthcare provider is very important and can be the factor that determines engagement in treatment or indeed a return to drug use. But it is not just choice that is the issue here. If we only have one drug and for some unforeseeable reason it cannot be accessed, then that is a huge issue.”
Government response and industry implications
A federal health department spokesperson said “any proposed discontinuation of a medicine can cause concern for patients and clinicians” but noted that “these are commercial decisions made by private companies, and the Australian government cannot compel a company to continue supply”. Adjunct Professor Brendan Shaw from the University of Sydney’s pharmacy school, a former chief executive of Medicines Australia, said pharmaceutical companies are increasingly examining the impact on global markets when they agree to supply cheaper medicines to Australia under the PBS. He stated: “What the US position has done is draw these debates out into the light, and companies are scrambling, frankly. It sort of caused chaos across the industry and the health sector worldwide as the companies all readjust to this.” Shaw added that he suspected more drugs might be pulled from the Australian market because of “pressures that are building internationally”.
Data on opioid dependence treatment
On a snapshot day in 2025, 57,740 Australians were receiving some form of pharmacotherapy treatment for opioid dependence, according to the latest data from the Australian Institute of Health and Welfare. Indivior said it intends to work with appropriate authorities and experts in Australia to ensure an orderly transition that minimises disruption.
