What is Todacitan, a drug to stop smoking?

Since February 1, 2023, spain experimented the Todacitan (marketed by the EFG/Aflofarm laboratory), a smoking cessation medication in the form of tablets which would allowquit smoking in just 25 days. However, not all smokers have access to it. Following the conclusive results of several randomized trials, the Spanish Ministry of Health has indeed authorized its issuance and reimbursement only For “heavy smokers” followed in anti-tobacco centers. What is Todacitan? What is his mode of action ? What Side effects ? Will it be available in France one day?

What is Todacitan?

Todacitan (from the EFG/Aflofarm laboratory) is smoking cessation treatment based on cytisine. It helps to quit smoking gradually and relieves quitting anxiety. Cytisine is a molecule derived from a plant (Cytisus Laburnum, see photo below) used as an anti-smoking treatment in Eastern Europe since 1967, reports the site Swiss Tobacco Stop. Cytisine has an agonist effect, such as Champix® (smoking cessation drug withdrawn from the market in France in 2021). This means that she is able to block the binding of nicotine to specific receptors (nicotinic alpha 4-beta 2)what decreases dopamine secretion (nicknamed the “happiness” hormone) when a smoker consumes tobacco. In other words, the smoker takes less pleasure in smoking. Moreover, cytisine alleviates unpleasant symptoms associated with quitting smoking (anxiety, stress, desire to snack, etc.).

What are the indications for Todacitan?

Todacitan is indicated to adults (over 18) wishing to quit smoking and who have no contraindications (see list below). This treatment is for people who smoke more than 10 cigarettes a day and who are monitored in anti-tobacco centres.

In all cases, Todacitan must be taken following a prescription by a doctor who ensures that there are no contraindications. The treatment lasts 25 days:

► From day 1 to day 3: the patient takes 6 tablets of 1.5 mg per day (1 every two hours). During these first 3 days of withdrawal, the patient can continue to smoke a few cigarettes.

► From day 4 to day 25: the patient takes 2 tablets of 1.5 mg per day (2h30 apart). From the 4th day, the patient must completely stop smoking. After 25 days, the patient theoretically no longer wants to smoke.

Will the Todacitan arrive in France?

In France, Todacitan is not allowed.

For the moment, Todacitan du EFG/Aflofarm laboratory is not available than in Spain and that for some smokers (smoking more than 10 cigarettes a day and monitored by anti-smoking centres), but also in 18 countries (Eastern Europe, Canada, etc.) on prescription medical. But Todacitan is not approved by drug control authorities in France. It remains to be seen whether this drug will one day be authorized and marketed in France. “Cytisine has a small efficacy in the tests that have been carried out. But for now, we don’t have major indisputable trials to give it drug status. It’s an interesting track“explained the Professor Dautzenberg on RTL. Note that Todacitan has a mode of action similar to that of Champix®, a drug based on varenicline (but with fewer side effects a priori). Champix® was the only smoking cessation drug marketed in France. But it was withdrawn from the market in October 2021 because of the presence of a probably carcinogenic substance. For the moment, it is not back on the French market. As an alternative to Champixthe prescription of an alternative treatment such as nicotine replacement therapy (patches, erasers, sprays…) and the bupropion hydrochloride (Zyban) is also possible to quit smoking.

How effective is Todacitan?

The effectiveness of Todacitan has been demonstrated by several randomized trials, versus placebo (the placebo is a drug form without active product but identical in appearance to that of the active drug). Imost recent study (July 2021) compared the efficacy of cytisine (Todacitan) with that of varenicline (Champix®) in 1,500 patients. Six months after taking treatment, abstinence rates were 11.7% for the group that took cytisine (25-day treatment) and 13.3% for the group that took varenicline (84-day treatment), with fewer side effects for cytisine.

What are the side effects of Todacitan?

Cytisine is generally well tolerated. According the 2013 meta-analysis And that of 2019the most frequently reported adverse events are:

• Mild to moderate gastrointestinal symptoms
• Headache
• Insomnia
• Nausea
• Vomiting
• Dyspepsia (abdominal discomfort)
• Dry mouth

What are the contraindications of Todacitan?

Do not take Todacitan:

• if you are allergic to cytisine or any of the other ingredients of this medicine
• if you suffer from unstable angina (angina pectoris),
• if you have a history of recent myocardial infarction,
• if you suffer from clinically relevant cardiac arrhythmias,
• if you have recently had a stroke,
• if you are pregnant or breastfeeding
• if you are on the birth control pill
• if you are taking antiepileptic treatment
• if you are taking TB treatment
• if you have high blood pressure that is not well controlled

Sources: Stop-Tabac.ch website / Efficacy of cytisine in helping smokers quit: systematic review and meta-analysis. Thorax. 2013 Nov;68 / Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial. JAMA. 2021 / Availability of health products, ANSM / Smoking cessation: what support for nicotine substitutes? AMELI, October 26, 2022 / Aflofarm website