BOSTON — The first drug that helps vapers quit using e-cigarettes may be nearing FDA approval. Researchers at Massachusetts General Hospital have found that a plant-based drug called cytisinicline shows tremendous promise for calming the urge to vape. Cytisinicline has already shown an ability to help smokers give up traditional tobacco cigarettes.
Study authors note that 11 million adults in the U.S. use e-cigarettes, specifically to vape nicotine. However, roughly half of them have expressed an interest in quitting, according to researchers. Despite their desire to kick the habit, studies continue to show the powerfully addictive effect of using nicotine.
In the new study, published in JAMA Internal Medicine, researchers conducted a double-blind randomized clinical trial involving 160 adults who vaped but didn’t smoke cigarettes. For 12 weeks, the participants either took cytisinicline in pill form or a harmless placebo.
Results show that those taking cytisinicline were more than twice as likely to quit vaping by week nine than those taking placebos (31.8% vs 15.1%). The team also found that participants suffered very few, if any, side-effects from using the plant-based drug.
“No medication has been approved by the FDA for vaping cessation in the United States,” says lead author Nancy A. Rigotti, MD, the director of Massachusetts General Hospital’s Tobacco Research and Treatment Center and a professor of medicine at Harvard Medical School, in a media release. “Our study indicates that cytisinicline might be an option to fill this gap and help adult vapers to stop using e-cigarettes.”
So, what makes cytisinicline such a promising medication for those trying to quit vaping? The study discovered that cytisinicline binds to nicotine receptors in each patient’s brain cells. This is why the drug appears to be a promising medication for both smokers and vapers, as both tobacco cigarettes and e-cigs use nicotine.
“The results of our study need to be confirmed in a larger trial with longer follow-up,” Rigotti concludes, “but they are promising.”
Despite the promise of cytisinicline as an anti-smoking and vaping medication, FDA approval could still take a while to come through.
What steps do drugs go through to reach patients?
Developing a new drug or vaccine is a complex and rigorous process that can take up to several years. This process is carefully regulated to ensure the safety and effectiveness of the drug. The process includes the following stages:
Preclinical Testing: This is the initial stage of drug development. It involves laboratory experiments to understand the drug’s effect on certain cells. In this case, it could be a patient’s brain cells. This phase includes both in vitro (in the lab, often in petri dishes) and in vivo (in animal models) testing.
Investigational New Drug Application (IND): In this step, the drug’s developers compile the results from the preclinical testing and submit an IND application to a regulatory agency such as the U.S. Food and Drug Administration (FDA).
Clinical Trials: Clinical trials involve testing the drug in humans and are generally conducted in three phases:
- Phase I: This is the first stage of testing in humans. The primary goal is to evaluate the drug’s safety, determine a safe dosage range, and identify side effects.
- Phase II: The focus here is on evaluating the drug’s effectiveness and further assessing its safety. This phase involves more participants who have the condition that the drug is intended to treat.
- Phase III: This phase involves randomized and blind testing in several hundred to several thousand patients. The aim is to confirm the drug’s effectiveness, monitor side-effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.
New Drug Application (NDA): If the results from the clinical trials are positive, the drug’s developers can submit an NDA to the FDA (or a similar application to other national regulatory bodies).
FDA Review: The FDA then reviews the NDA. If the FDA approves the application, the drug becomes available for physicians to prescribe to patients.
Post-Marketing Surveillance (Phase IV Trials): After a drug is approved, it’s continually monitored for safety in what are known as Phase IV trials. If new side-effects or problems are detected, the FDA can choose to remove the drug from the market or change its usage guidelines.
It’s important to note that many drugs never make it through this entire process. Estimates show that for every 5,000 to 10,000 compounds that enter preclinical testing, only one is approved for patient use.
