Cytisinicline shows promise for smoking cessation in large U.S. study

An American Phase 3 clinical trial indicates that the plant molecule cytisinicline is effective when combined with behavioural support for smoking cessation. These results, published in the Journal of the American Medical Association on July 11, are based on data collected during the ORCA-2 clinical trial of 810 individuals who smoked. The anti-smoking effects of this molecule extracted from laburnum seeds were already known. It is a partial agonist of the α4β2 nicotinic acetylcholine receptor. This is the first large trial of this medication conducted in the United States. It has been approved by Health Canada since 2017 under the name Cravv as a natural health product without a prescription, and not as a drug that would require a more demanding approval process. The research team assessed the smoking abstinence rate in three randomized groups: 12 weeks of cytisinicline treatment; six weeks of this treatment followed by six weeks of placebo; 12 weeks of placebo. All participants received additional behavioural support. The group that took cytisinicline for 12 weeks had the best results. After nine weeks of treatment, the abstinence rate for these participants was 32.6%, compared to 7% for the placebo group. Between weeks nine and 24, the group maintained an abstinence rate of 21.1%, while the placebo group dropped to 4.8%. Finding effective alternatives to tobacco control is urgent, according to Dr. Nancy Rigotti, principal investigator of the ORCA-2 clinical trial and professor at Harvard Medical School, as tobacco remains a major source of preventable deaths. Read: Millions across the world live with low back pain, but addressing major risk factors like smoking, obesity and workplace ergonomics could curb the trend According to the Canadian Tobacco and Nicotine Survey, 10.2% of people aged 15 or older reported smoking regularly in 2021, and 48,000 people die of related causes every year in Canada. In their study, the researchers tested a concentration of 3 mg, administered three times a day. However, the study does not compare the effectiveness of cytisinicline to other treatments already available on the market. In Canada, medications such as Champix (varenicline) and Zyban (bupropion) are indicated for smoking cessation. There are also nicotine replacement therapies (NRTs) in the form of patches, gummies and lozenges. According to a study conducted in New Zealand on 1,310 smokers, published in 2014 in the New England Journal of Medicine, cytisinicline would be more effective than NRTs in quitting smoking. This same study nevertheless found that cytisinicline produced more adverse effects than NRTs. Minimize adverse effects In general, "The treatments currently available do not help all smokers to quit and produce unacceptable side-effects in others," estimated Dr. Rigotti, also director of the Center for Treatment and Research on Tobacco at the Massachusetts General Hospital. The U.S. research team rated the tolerance to cytisinicline as "excellent." Less than 10% of participants in each group reported nausea, abnormal dreams or insomnia. Of the 810 participants, 16 had to discontinue treatment due to adverse reactions, or 2.9% of all participants. Simon Lessard, pharmacist-owner certified in respiratory health, welcomes the results of the clinical trial. “We will always need different alternatives for smoking cessation. There is no one product that works for everyone,” he said. However, he noted that the existing treatments are well tolerated by the patients he follows. "There are precautions [to take] but not many contraindications . . . withdrawal symptoms are the most difficult to manage," he said. These symptoms include anxiety, nervousness, uncontrollable impatience, insomnia and tremors. The most important thing for quitting smoking is above all the motivation to quit and patient belief in the effectiveness of the treatment, according to Lessard. Behavioural support can also be beneficial, in addition to or independently of any treatment. “Therapies have been shown to be important factors [in quitting smoking]. The problem is a problem of access and willingness on the part of the patient to follow them,” added the pharmacist. Read: When we present medical facts to patients, why don’t they listen? Achieve Life Sciences, the pharmaceutical company that initiated and financed the study, said in a press release that it aims to market cytisinicline and plans to file for approval with the U.S. Federal Food and Drug Administration by the first half of 2024. This article has been translated from its original French and first appeared on our sister site Profession Santé.

Cytisinicline shows promise for smoking cessation in large U.S. study

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