Achieve Life Sciences CMO speaks at FDA, NIH Smoking Cessation Public Meeting

Achieve Life Sciences (ACHV) announced that Dr. Cindy Jacobs, Achieve’s President and Chief Medical Officer, presented at the U.S. Food and Drug Administration and the National Institutes of Health Joint Public Meeting on “Advancing Smoking Cessation: FDA and NIH Priorities” held on October 21, 2024. The public meeting was initiated by Robert Califf, M.D., who currently serves as the 25th Commissioner of the FDA. The meeting included other representatives from the FDA, the NIH, the National Institute on Drug Abuse, and key academic and industry organizations with the stated focus of the meeting on accelerating innovation to advance treatments for smoking cessation. “We are appreciative that the FDA and NIH are making an effort to bring together experts who share a common goal of reducing the number of lives lost every year due to smoking-related diseases,” stated Dr. Jacobs. “It has been nearly two decades since a new prescription smoking cessation treatment has been approved by the FDA. Cytisinicline is currently the only nicotine dependence treatment in late-stage development. We have completed two randomized Phase 3 clinical trials in over 1,600 subjects demonstrating robust evidence supporting safety and efficacy, based on the gold-standard clinical endpoint of continuous smoking cessation. We are currently working to complete a longer-term safety exposure study in subjects and look forward to our continued engagement with the FDA as we move towards our NDA filing and potential approval.” Dr Jacobs was one of 10 participants at the meeting selected to deliver a 4-minute presentation. In her presentation Dr. Jacobs reminded the attendees that cytisine has been a smoking cessation treatment for decades in Eastern and Central Europe. She also pointed out that although the efficacy and safety profile has been well-established for this older marketed product, the treatment involves a complex 25-day titration regimen. Dr. Jacobs highlighted Achieve’s redevelopment of this drug into a novel treatment for nicotine addiction, now known as cytisinicline. This new cytisinicline product features a revised formulation and tablet strength, easier streamlined dosing schedule, and extended treatment durations, demonstrating strong efficacy and excellent safety in the completed Phase 3 trials. In closing, Dr. Jacobs urged the FDA to re-assess how new drugs are being approved for smoking cessation treatment, especially given that no new prescription medications have been approved in nearly two decades, versus how other new nicotine or tobacco products are being approved in the US.