‘Cold war’ smoking treatment: Australian doctors lobby for regulatory approval

Nicotine patches are losing their PBS subsidy. A cheaper  treatment  is about to become available.

Nicotine patches are losing their PBS subsidy. A cheaper treatment is about to become available.

The Royal Australian College of General Practitioners (RACGP) is lobbying for regulatory approval of a quit-smoking treatment that was developed in Eastern Europe during the Cold War.

The drug is reportedly cheaper and more effective than nicotine patches and gums.

In the 60 years since the drug, cytisine, has been prescribed in Eastern Europe, no western country has adopted it.

Suddenly, that has begun to change

Cytisine (formally known as cytisinicline) was last month made available in the UK on prescription.

The UK’s shift in policy on cytisine followed a number of phase 3 trials that found it effective in helping people give up smoking tobacco, with relatively mild side effects.

In May, Seattle biotech Achieve Life Sciences, after publishing encouraging results of a clinical trial, said it would seek approval from the US FDA to market cytisine as an aid for quitting smoking.

Stat News suggested the company would face “stiff competition”.

What is cytisine?

Cytisine is found in the seeds and other parts of certain legumes.

These plants contain an alkaloid that binds selectively to nicotinic receptors in the brain that regulate nicotine dependence.

Cytisine is an alkaloid found in the common laburnum or Golden Chain tree. Photo: Getty

This alleviates the urge to smoke and reduces the severity of nicotine withdrawal symptoms.

According to a New Zealand study, it is at least as effective as nicotine replacement in helping smokers quit and avoid relapses.

Healthline declared that cytisine was cheaper to use than nicotine patches or gums.

Nicotine patches are about to lose their PBS subsidy

RACGP president Dr Nicole Higgins said in a statement: “Unfortunately, some of the approved medications for smoking cessation, including nicotine replacement therapy options like patches, are set to be removed from the Pharmaceutical Benefits Scheme in a few months’ time.”

The RACGP has asked the federal Health and Aged Care Minister Mark Butler to intervene “otherwise, we will regress in our fight against nicotine use in Australia”.

“In the meantime, approving this new medicine cytisine will also play a key role in helping patients quit nicotine,” Higgins said.

She said that with more people taking up nicotine vaping, additional tools were needed to help people quit.

Higgins said that cytisine has a proven track record in smoking cessation and has minimal side effects.

She said it was “sorely needed to tackle the ongoing battle of nicotine addiction, particularly among our youth”.

The strange twist

Western countries, including Australia, have marketed a similar drug for some years.

It’s called varenicline, designated as a first-line pharmacotherapy for smoking cessation. It is PBS listed.

In a 2021 study from UNSW’s National Drug and Alcohol Research Centre (NDARC), cytisine and varenicline groups of participants were compared over a six-month period.

The study found “11.7 per cent of participants in the cytisine group remained abstinent from tobacco smoking for six months, whereas 13.3 per cent of the varenicline group remained abstinent across the same time period”.

The researchers found cytisine “was associated with fewer side effects than varenicline”.

Lead author Dr Ryan Courtney said people often stopped use of smoking cessation aids because of side effects, such as nausea.

“We found adverse events for cytisine users occurred less frequently compared to varenicline, with participants reporting nausea and abnormal dreams significantly less,” Courtney said.

“This is an encouraging result that may lead to more smokers taking up this treatment option, as we know such adverse effects often lead to treatment discontinuation.”

Courtney also cited the drug’s low cost as “a critical factor” in promoting cytisine to regulators.

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