The first new drug for smoking cessation in 20 years is expected to come out

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The first new drug for smoking cessation in 20 years is expected to come out

JAMA: The first new drug for smoking cessation in 20 years is expected to come out.

“Smoking is harmful to health” is not only a common sense of health known to all ages, but also a warm reminder printed on every pack of cigarettes.

Harmful substances such as nicotine and tar in tobacco will enter the respiratory system, damage the epithelial cells of the lungs, and cause abnormalities in the respiratory system; smoking can also cause sympathetic nerve excitement, which will increase the heart rate of the human body, increase the load on the heart, and affect heart health.

In addition, the chemical substances contained in tobacco can harm human cells and induce various cancers such as gastric cancer, esophageal cancer, pharyngeal cancer, and lung cancer.

For old smokers who are addicted to smoking, although they have made up their minds to quit smoking countless times, most of them end in failure in the end. “Tobacco dependence” makes quitting smoking an extremely painful thing.

At present, the first-line clinical smoking cessation drugs are mainly divided into two categories: nicotine replacement therapy smoking cessation drugs and non-nicotine smoking cessation drugs.

Recently, the smoking cessation drug Cytisinicline developed by the research team of the Massachusetts General Hospital in the United States has initially completed the first of the third phase of clinical trials. The clinical results are positive, and it is expected to help smokers achieve painless smoking cessation.

On July 11, 2023, a research study entitled: Cytisinicline for Smoking Cessation A Randomized Clinical Trial was published in the medical journal JAMA .

This large-scale clinical trial mainly studies the effect of Cytisinicline for smoking cessation . The data show that the drug has good efficacy and tolerability, and can effectively withdraw the subjects’ dependence on nicotine.

The first new drug for smoking cessation in 20 years is expected to come out

Cytisinicline/Cytisine , known as “cytisine” in Chinese , is a plant alkaloid with high binding affinity with nicotine acetylcholine receptors, which can selectively act on the nicotinic receptors in the brain that regulate nicotine dependence and relieve the urge to smoke , reduces the severity of nicotine withdrawal symptoms, and its mechanism of action is similar to that of Varenicline, a smoking cessation aid approved by the US Food and Drug Administration (FDA).

Test setup

The ORCA-2 trial was a 3-arm, double-blind, placebo-controlled, randomized trial of 810 adults who smoked daily and wanted to quit, at 17 sites in the United States. The trial was designed to evaluate Cytisinicline 3 mg three times daily for 6 or 12 weeks compared with placebo , with follow-up lasting 24 weeks.

The primary endpoint of the trial was biochemically verified successful smoking cessation measured within the last 4 weeks of treatment. All participants received behavioral support.

Therapeutic results of cytisine

In the 12-week cohort, 32.6% of participants using Cytisinicline quit smoking between weeks 9 and 12, compared with 7% of participants using placebo ;

For the 6-week cohort, the abstinence rate was 25.3% for Cytisinicline between weeks 3 and 6 compared to 4.4% for placebo . Participants taking Cytisinicline also experienced a rapid and sustained decrease in their appetite and desire to smoke during the first 6 weeks of treatment.

In the long-term, the ORCA-2 trial found a statistically significant increase in sustained abstinence for 6 months at both treatment durations . The abstinence rate from week 9 to week 24 in the 12-week group was 21.1%, compared with 4.8% in the placebo group; the abstinence rate from week 3 to week 4 in the 6-week group was 8.9%, compared with 2.6% in the placebo group .

Cytisinicline was well tolerated by the subjects, there were no serious drug-related adverse events reported, and the incidence of typical side effects such as nausea and insomnia was low.

The first new drug for smoking cessation in 20 years is expected to come out

Nancy Rigotti , director of the MDGH Center for Tobacco Research and Treatment and author of the study, said, “Smoking remains the leading preventable cause of death worldwide, but in the past two years, the US FDA has not approved new smoking cessation drugs, so we urgently need new ones.” Drugs to treat smoking problems. Cytisinicline, a smoking cessation drug, has achieved impressive results in rigorous clinical trials, has unlimited potential for smoking cessation, and may be effective in reducing the number of premature deaths or disabilities caused by smoking around the world .Given its fewer side effects, cytisinicline may be a valuable new option for the treatment of tobacco dependence .”

If cytisine is successfully approved for marketing, it may become the first innovative prescription therapy in the past 20 years.

As a new therapy to assist smoking cessation, it can help countless smokers overcome nicotine dependence and provide highly effective treatment for quitters choose.

References :
[1]Rigotti NA, Benowitz NL, Prochaska J, et al. Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2023 Jul 11;330(2):152-160. doi: 10.1001/jama.2023.10042. PMID: 37432430.