The drug that makes you stop smoking in 25 days is now reimbursed: here's what to know about cytisine

A cluster of small yellow flowers similar to wisteria guards: this is Cytisus laburnum, also known as laburnum, a plant of the Leguminosae family from which cytisine is extracted, the active ingredient of the new drug produced by the Polish company Adamed and marketed in Italy by Laboratorio Farmaceutico C.T., which has just been published in the Official Gazette and is now available for Italian smokers wishing to quit.

Already present in the World Health Organisation guidelines (2024), and included in the list of essential molecules in 2025, cytisine from galenic formulation will thus become a drug reimbursable by the National Health Service. For the time being, as mentioned, only if dispensed by smoke-free centres. Then we will see.

Meanwhile, the introduction of pharmaceutical cytisine within the protocols of smoking cessation pathways can - it is the promise - improve the effectiveness of treatments, facilitate access and equity thanks to the molecule's reimbursability, and generate savings for the National Health Service.

Cytisine acts on the same receptors activated by nicotine with unique chemical and pharmacological characteristics: it is able to alleviate the withdrawal symptoms produced by smoking nicotine, resetting the positive reinforcement induced by nicotine and all the bio-behavioural prerequisites underlying smoking addiction.

In practice, cytisine, by blocking receptors in our brain, decreases the pleasure associated with smoking by modulating mood and reducing all the symptoms that occur during nicotine withdrawal (irritability, dysphoria, insomnia, anxiety), the main drivers of relapse.

Citisin is administered orally according to a standard protocol of 25 days, with a gradual reduction in dosage.

This dosing schedule - which each patient, as with the contraceptive pill, finds behind each blister pack to simplify intake - has been validated in numerous clinical studies and is the most established and effective modality of use in the treatment of Tobacco Use Disorder (TAD).

'Because of its proven efficacy, safety profile, and high cost/benefit ratio, cytisine is a drug that is particularly suitable for integration into multidisciplinary treatment pathways for tobacco use disorder,' emphasises Dr Claudio Leonardi, President of Sipad, the Italian Society for Addiction Disorders. The decreasing dosage scheme was developed with the aim of alleviating nicotine withdrawal symptoms and facilitating smoking cessation. Complete cessation of tobacco use should occur by day 5 after the start of treatment'.

The absence of known proven drug interactions makes cytisine particularly recommendable in patients who are frail, chronically ill and on polypharmacological therapy. Side effects, should they appear, are generally mild and temporary, with an excellent long-term tolerability profile

"Cytisine must be considered a first-line therapeutic option also in the light of its recent introduction among the drugs reimbursable by the SSN," stresses Dr. Fabio Beatrice, Chief Emeritus of the San Giovanni Bosco Hospital in Turin and Scientific Director of MOHRE. "Considering the transversal nature of smoking-related damage, its use must be through the prescription of general practitioners, pulmonologists, oncologists and territorial cardiologists, SerD professionals and all other specialists involved in the treatment of pathologies that may be affected by the presence and persistence of Dut.

Tobacco use disorder is responsible for more than 90,000 deaths every year in Italy and smoking-related health costs, between public expenditure and loss of productivity, exceed EUR 26 billion annually.

It is also one of the leading preventable causes of death and disability globally.

According to estimates by the Italian Association of Medical Oncology - engaged with the Airc Foundation, the Umberto Veronesi Foundation and the Aiom Foundation in the signature collection campaign aimed at the popular initiative bill to increase the cost of all smoking and nicotine inhalation products by 5 euro - a person's overall life expectancy can be reduced by 20 minutes for every cigarette smoked and people who smoke all their lives lose about 10 years. Despite available prevention strategies and treatments, smoking cessation remains a clinical and public health challenge. Increasing access to effective treatments for 'smoking' is a cost-effective as well as a preventive and strategic measure.