First FDA-Approved Plant-Based Drug "Cytisinicline" Helps Smokers Quit E-Cigarettes

According to a report by JAMA Internal Medicine on May 6th, researchers at Massachusetts General Hospital in the United States have developed the first drug to help smokers quit e-cigarettes, a plant-based medication called "Cytisinicline". It is currently on track to receive approval from the US Food and Drug Administration (FDA).

A new study published in the Journal of the American Medical Association (JAMA Internal Medicine) has shown that a drug developed by a general hospital in Massachusetts, called Golden Thistle Alkaloid, has significant potential in aiding smoking cessation. The drug is expected to receive full approval from the FDA and become the first medication approved for helping individuals quit e-cigarettes. The co-authors of the study report that approximately 11 million American adults use e-cigarettes containing nicotine, with about half expressing a desire to quit smoking.

According to a new study, a double-blind randomized clinical trial involving 160 e-cigarette users who did not use traditional tobacco was conducted. During the 12-week trial, they were either given cytisine tablets or a harmless placebo. The results showed that those treated with cytisine were more likely to quit smoking by the ninth week compared to those taking the placebo (31.8% vs. 15.1%). The research team also found that there were very few, if any, side effects for participants who took cytisine tablets.

Nancy A. Rigotti, MD, director of the Tobacco Research and Treatment Center at Massachusetts General Hospital and professor of medicine at Harvard Medical School, stated, "In the United States, no medication has been approved for quitting e-cigarettes yet, and our research suggests that varenicline could fill this gap and help adults quit using e-cigarettes."

The magic of lobeline lies in its ability to bind with nicotine receptors in the brain cells of smokers, making it a promising medication for both smokers and e-cigarette users. While lobeline is seen as a hopeful treatment for tobacco and e-cigarette cessation, it will still require some time to receive full approval from the FDA.

During this process, many drugs ultimately fail to withstand the full course of testing. It is estimated that out of every 5000 to 10000 compounds that enter preclinical trials, only one eventually receives approval for use in patients.

In the development process, drugs need to go through many steps before they can reach the hands of patients. The development of new drugs or vaccines is a complex and rigorous process that may take several years. This process is conducted under strict regulation to ensure the safety and effectiveness of the medication. It includes various stages such as preclinical trials, Investigational New Drug (IND) studies, and clinical trials, before the drug can be prescribed by doctors to patients after FDA approval.