Yammine presents research at joint NIH and FDA meeting

Luba Yammine, PhD, associate professor in the Faillace Department of Psychiatry and Behavioral Sciences, recently presented her ongoing research at the joint National Institutes of Health (NIH) and Food and Drug Administration (FDA) public meeting on advancing smoking cessation priorities.

It’s been 17 years since the FDA approved the last smoking cessation medication. Although the prevalence of cigarette smoking has decreased substantially over the last several decades, Yammine said, smoking is still a major public health problem. Over 16 million Americans are currently living with smoking-related diseases. Cigarette smoking also contributes to nearly half a million deaths in the U.S. each year.

There are several FDA-approved therapies for smoking cessation, however, the existing treatments do not work for everyone. To further decrease the prevalence of smoking, there is a great need to expand the range of treatment options, Yammine said. The public meeting, which was held at the FDA headquarters in Silver Springs, Maryland on October 21, 2024, was attended by representatives from the NIH and FDA, and scientists and clinicians. It was designed to bring together critical stakeholders in supporting research on, and development of, new interventions to help people of all ages, including underserved and vulnerable populations, stop smoking.

The meeting agenda included updates from the NIH regarding current smoking-related research and areas of opportunity, an overview of the FDA regulatory framework, clinical and community perspectives, and paths forward. Yammine was invited to present in a session dedicated to promising targets for further development. Her talk focused on the potential role of GLP-1 agonists for helping people stop smoking and preventing post-cessation weight gain.

Yammine is currently leading two clinical trials examining GLP-1 agonists in the context of smoking cessation: an NIH-funded trial of exenatide, and a trial of semaglutide funded by its manufacturer Novo Nordisk. The trials enroll people who smoke who are overweight or obese and assess targeted mechanisms of change in addition to smoking and weight outcomes.

are actively enrolling participants.

“We received great feedback from people participating in our studies,” Yammine said. “We do have an amazing research team, and participants note how much they look forward to attending clinic visits and interacting with our caring and supportive staff.”

The studies are double-blind, placebo-controlled, meaning neither the researchers nor the patients know who receives the active treatment. The primary hypothesis is that GLP-1 agonist treatment will be associated with higher smoking cessation rates and lower post-cessation weight gain.

Yammine is eager to see the results of this research which attempts to repurpose the existing medications for a new indication. GLP-1 agonists are already used widely in clinical practice for the treatment of type 2 diabetes and weight management.

“If our hypotheses are confirmed, the time to market for these medications would be shortened, making them available sooner to people who need them,” Yammine said.

Click here for more information on the studies.