How it works and how much it costs all quotethe new drug for stop smoking? With the withdrawal of the Champixthe most popular drug for tobacco addiction, and the supply problems of Zyntabacits alternative, from this month the Spanish Social Security finances Todacitan, from the Polish laboratory Aflofarm.
Why i talk so much about Todacitan?
In September 2021, the withdrawal of Champix from the market ordered by theSpanish agency for medicines and health products (Aemps) and the abandonment of its production by Pfizer, due to the presence of carcinogenic nitrosamine impurities in the drug, undermined the Spanish anti-smoking strategy.
In this year and a halfmany smokers who wish to fight their tobacco addiction have found themselves in a delicate situation due to the price of the most effective treatments and their adverse effects, which are not uncommon in many people.
Since February, the public health service has been subsidizing Todacitan, a drug that has been on the market for a year and costs more 198 euros for a 25-day treatment cycle.
What is Todacitan?
According to the Aemps package insert, Todacitan is a smoking cessation aid and serves “to relieve the anxiety that occurs when you stop smoking.” He adds: «The use of Todacitan allows to gradually reduce the dependence on nicotine, alleviating the symptoms of withdrawal».
Todacitan is based on an active ingredient of plant origin called cytisine, which is an alkaloid analogue of nicotine. In other words, it is identified by the nicotine receptors themselves and then takes its place in the body, preventing the nicotine from taking effect.
The “trick” is that although cytisine’s blockade of nicotinic receptors eliminates the craving and addictive effects of nicotine, cytisine does not generate dependence, at least for short periods of time, which are those established for treatment.
In fact, cytisine is an old acquaintance from Eastern Europe, as it is found in a local tree called laburnum (Laburnum anagyroides), whose leaves have been smoked since ancient times as a tobacco substitute.
Furthermore, the seeds, which contain the alkaloid, are used as a pain reliever for the central nervous system and in cases of brain pain and depression.
As this British Medical Journal article explains, during World War II the leaves were smoked by soldiers of both sides to help them overcome cravings when tobacco was in short supply, as it often was.
Subsequently, in 1964, the first cytisine-based smoking cessation drug was produced and marketed in Bulgaria under the name Tabex.
Proven effectiveness
According to several studies published in prestigious scientific journals such as the New England Journal of Medicine and the Journal of the American Medical Association, the effectiveness of this active ingredient has been demonstrated.
In a study published in 2011 in the New England Journal of Medicine, treatment with cytisine for 25 days showed higher one-year abstinence rates than placebo.
In addition, prolonged abstinence at six months was 10% of patients treated with cytisine compared to 3.5% with placebo. Data for the risk of prolonged abstinence at six and 12 months were 2.9% and 3.4%, respectively.
Another 2014 study, published in the same journal, compared cytisine therapy with nicotine replacement therapy (NRT). Patients receiving 25-day cytisine therapy had higher abstinence rates than those taking NRT at one month: notably 40% versus 31% after eight weeks of NRT. Furthermore, the time to relapse was longer with cytisine than with NRT.
Finally, a study published in the Journal of the American Medical Association compared the effectiveness of cytisine with varenicline, another smoking cessation agent and the basis of Zyntabac, a now-withdrawn drug.
Abstinence rates after 25 days with cytisine were11.7%, compared to 13.3% after 12 weeks with varenicline. However, in this study, patients taking cytisine had fewer adverse effects than those taking varenicline.
Side effects
The list of adverse effects of Todacitan, which do not necessarily occur in all people or with the same intensity, is long:
- changes in appetite
- weight gain
- dizziness
- irritability
- mood swings
- anxiety
- increased blood pressure
- increased heart rate
- dry mouth
- diarrhea
- constipation
- skin rashes
- sleep disorders
- heachache
- taste alteration
- stomach ache
- nausea
- vomit
- abdominal pains
- muscle aches
Its use is therefore not recommended for pregnant women, nursing mothers and people who have had a stroke or are at risk of cardiovascular disease.
It is also not recommended for people to over the age of 65those under 18 years of age and those with liver or kidney problems, due to lack (or little) clinical experience of use in this group of people.
How to take Todacitan
According to Cima’s package insert, one pack of Todacitan (100 tablets) is sufficient for a complete course of treatment lasting 25 days. Todacitan is for oral use and should be taken according to the following schedule:
From the 1st to the 3rd day: 1 tablet every 2 hours and a maximum of 6 tablets.
From the 4th to the 12th day: 1 tablet every 2.5 hours and a maximum of 5 tablets.
From the 13th to the 16th day: 1 tablet every 3 hours and a maximum of 4 tablets.
From the 17th to the 20th day: 1 tablet every 5 hours and a maximum of 3 tablets.
From the 21st to the 25th day: 1-2 tablets per day and a maximum of 2 tablets.
How much does the treatment cost?
The price of Todacitan is currently 116.93 euros. As the OCU explains, “depending on the level of contribution that the patient must bear, the cost of this drug for active workers, through a prescription from the National Health System, can vary from 46.77 euros to 70.16 euros” .
It should be remembered that the health service, whether state or autonomous community, it only funds one treatment a yearso if you fail on the first try, the fight against relapse will have to be done out of pocket.
On the other hand, treatment is funded only for people enrolled in the smoking cessation support program in force in the autonomous community concerned.
In addition, they must demonstrate an expressed motivation to quit smoking, with evidence of a quit attempt within the past year. They also have to smoke ten or more cigarettes a day and have a high level of addiction according to the Fagerström test (score equal to or greater than 7).
What is the alternative in Italy
In Italy there is a free anti-smoking drug prepared thanks to the collaboration between the Center for the treatment of tobacco addiction of the Addiction Service and the Asl hospital pharmacy of Asti.
Pharmacological therapy is a valid support for reducing withdrawal symptoms and limiting the desire to smoke and is recommended for people who smoke more than ten cigarettes a day or have developed a strong addiction. The drug is cytisine and is distributed free of charge in the form of capsulesfollowing a medical evaluation carried out within the Centre.
The capsules are prepared in the galenic laboratory of the hospital pharmacy and constitute an effective therapeutic support that is well tolerated by patients in the path of smoking cessation. The intake lasts a few weeks and helps limit the physical and psychological consequences of a lack of tobacco.
They accompany and integrate the pharmacological therapyguaranteeing a greater probability of success, the psychological support tools in the healthcare company outpatient clinics, such as motivational counseling or participation in support groups with the mindfulness technique (which is restarting after the interruption due to the Covid emergency), an effective practice both in helping the person to stop smoking and in preventing any relapses, through the acquisition of greater control of the impulse to smoke.
The Tobacco Treatment Centers (Ctt), managed by the Addiction Service, are present in Asti and a Nizza Monferrato and doctors, psychologists, educators and nurses work there. In the hospital of Asti there is also a clinic for smoking cessation managed by the pulmonology structure.
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