Associate Professor Ryan Courtney (Program Lead of the Tobacco Research Group at NDARC and a National Heart Foundation Future Fellow) and Dr Hayden Robbie (Visiting Professor at NDARC and Professor of Population Health at Queen Mary University of London) write about importance of cytisine being listed on the Australian Register of Therapeutic Goods for smoking cessation.

First new quit-smoking aid to be registered in 20 years

Cytisine, a plant‑derived medication used for smoking cessation in parts of Europe for close to five decades, has quietly arrived in Australian pharmacies. Its availability marks one of the most important developments in tobacco treatment in years, and it couldn’t come at a more critical time. This is the first new treatment (Cyventine^TM) for smoking cessation to be listed on the Australian Register of Therapeutic Goods since varenicline (Champix^TM) close to two decades ago.

Smoking remains one of the leading causes of preventable death in Australia, and while prevalence has declined, the burden is increasingly concentrated among people experiencing social and economic disadvantage. These are the communities least likely to access behavioural support, least able to afford prescription medicines, and most exposed to tobacco‑related harm.

Cytisine as a medication listed on the WHO Essential Medicine’s List, changes the equation.

A proven, affordable treatment is finally available in Australia

Cytisine is not new and it’s actually the world’s oldest treatment for smoking cessation. It was first isolated from seeds of common garden decorative plants Laburnum anagyroides (syn. Cytisus laburnum; Golden Rain) in 1862. Its leaves were smoked as a tobacco substitute by soldiers during the Second World War, and it was first authorised in Bulgaria, and sold as a stop-smoking medicine in Central and Eastern Europe since 1964. Because it is extracted from plants, some people find it more appealing than synthetic medicines; however, it is the standardised dose, not its natural origin, that makes it safe.

A small study with Māori, the Indigenous people of New Zealand (NZ), found strong interest in cytisine, particularly if it were presented as a rongoā Māori (traditional remedy), since it is also found in kōwhai, a native NZ tree.

Several high‑quality trials exist worldwide including the world’s largest active comparator trial conducted in Australia. This trial led by NDARC's Tobacco Research Group showed it had comparable effectiveness to varenicline, the most effective sole stop‑smoking medication therapy ever developed, but with fewer side effects. From a practical perspective with cytisine available in pharmacies as Schedule 3 (pharmacist only), it bypasses the need for medical consultation and prescription. It also has a much shorter treatment course of 25 days compared to 84 days for varenicline treatment. Whilst not yet available on the Pharmaceutical Benefits Scheme (PBS) it will be marketed at $89.99 recommended retail price and available in pharmacy dispensaries across the country.

Our 2021 JAMA trial found cytisine produced quit rates comparable to varenicline. With both an Addiction monograph and Cochrane review concluding cytisine increases long‑term quitting and is a safe, well‑tolerated, and cost‑effective quit aid.

Until now, Australians couldn’t access it.

Why cytisine matters for equity?

The arrival of cytisine is especially important for people who face barriers to quitting:

• Cost/Duration: Cytisine is comparable in cost to other prescription cessation medicines. Nicotine patch and varenicline is only available on the PBS which requires a doctor’s consult for authorisation with the most effective form of nicotine replacement therapy (NRT), combination treatment requiring substantial out-of-pocket costs to obtain oral forms of NRT (i.e. gum, lozenge or nicotine spray).
• Access: It can be dispensed directly through pharmacies to the consumer.
• Acceptability: It is derived from a natural plant extract, it is nicotine free and has a shorter treatment course and fewer adverse effects leading to higher tolerability compared to existing treatments.

For people who smoke daily and struggle to afford or tolerate existing medications, cytisine offers a practical, evidence‑based alternative.

A turning point for tobacco treatment in Australia

Australia has long been a global leader in tobacco control, but treatment has lagged behind prevention. Article 14 of the WHO Framework Convention on Tobacco Control calls on countries to provide accessible, evidence‑based cessation support. Cytisine’s arrival helps Australia meet that obligation.

How does it work?

Cytisine works by partially stimulating the same nicotine receptors in the brain that drive tobacco addiction, reducing withdrawal symptoms and the rewarding effects of smoking. It binds more strongly to these receptors than nicotine, which helps block nicotine’s ability to trigger pleasure when someone lapses. This combination of easing withdrawal and blunting reinforcement makes cytisine an effective aid for quitting smoking.

What’s the catch though?

Like all medicines it’s not for everyone. It’s authorised for use among adults (18 years or older) and those under the age of 65 years. It is not indicated for use for those over 65 years, largely because of an absence of evidence in use among older cohorts, as opposed to any safety flags or indicators. It should not be used by those that are pregnant or breastfeeding, those with renal or hepatic impairment or those with severe heart conditions i.e. unstable angina or those with recent heart attack, and use among those with stable cardiovascular conditions should be monitored.

Adverse reactions are rare and compared to all other treatments overall cytisine has a better adverse event profile than NRT and varenicline. However, mild to moderate gastrointestinal complaints, and sleep disturbance, headaches, and nausea are the most common adverse events. These symptoms are often mild, self-limiting, and dissipate quiet quickly and are also commonly associated with smoking cessation rather than use of a quit aid.

What needs to happen next?

Cytisine’s arrival is a major step forward, but its impact will depend on:

• Awareness among clinicians and pharmacists.
• Clear guidance on prescribing and use.
• Integration with behavioural support and embedding its use within existing clinical settings and outreach support services i.e. Quitline.
• Targeted outreach to high‑need communities.

Australia now has an opportunity to modernise its cessation system, combining low‑cost pharmacotherapy to reach people who have historically been left behind.

Cytisine won’t solve every challenge in tobacco control. But its availability is a long‑awaited and welcome addition to Australia’s treatment toolkit, one that could help thousands more people quit for good.