Achieve Life Sciences Submits NDA for Cytisinicline
Smoking continues to be a major public health issue affecting millions of adults in the U.S., with around 29 million individuals dealing with nicotine dependence.
Achieve Life Sciences, Inc. (NASDAQ: ACHV), a specialty pharmaceutical company, has recently made an exciting announcement regarding its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for cytisinicline as a treatment for smoking cessation. If approved, cytisinicline will represent the first new FDA-approved medication for nicotine dependence in two decades.
Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve Life Sciences, described the NDA submission as the culmination of ten years of research. "This submission signifies an important milestone in addressing nicotine dependence, a pressing public health challenge with limited treatment options. Smoking-related diseases result in nearly half a million annual deaths in the United States. We are eager to work with the FDA throughout the review process and believe that cytisinicline can significantly benefit patients and healthcare providers seeking effective treatment alternatives," shared Dr. Jacobs.
Clinical Trial Results for Cytisinicline
The NDA submitted by Achieve is backed by robust data from two extensive Phase 3 trials, ORCA-2 and ORCA-3, designed to evaluate the efficacy of cytisinicline for smoking cessation. In these placebo-controlled studies, participants taking cytisinicline for either six or twelve weeks, combined with standard behavioral support, reported significantly higher rates of abstinence compared to those on placebo treatments. The company also incorporated safety data from over 300 individuals who participated in the ORCA-OL open-label long-term trial and found no new safety concerns flagged by independent monitors.
According to Rick Stewart, Chief Executive Officer of Achieve Life Sciences, "This NDA submission is a pivotal step to enhance the well-being of adults battling nicotine dependence and furnish healthcare providers with an additional resource in the fight against smoking. The consequences of tobacco addiction are dire, affecting millions. It’s critical that we offer patients viable solutions to address this unmet medical requirement."
Commitment to Addressing Nicotine Dependence
Achieve Life Sciences is focused on the global battle against smoking and nicotine dependence through cytisinicline's development. The submitted NDA is based on successful completion of Phase 3 trials as well as fully enrolled Phase 2 studies that explored cytisinicline's efficacy for vaping cessation. Overall, there are no FDA-approved treatments currently available specifically for nicotine e-cigarette cessation, highlighting the importance of Achieve’s efforts.
Cytisinicline is a plant-based alkaloid that works by binding to nicotinic acetylcholine receptors in the brain. This mechanism helps to diminish nicotine cravings and the overall satisfaction derived from nicotine, making it a promising candidate for treating nicotine addiction.
Significant Mortality Rates from Smoking
Approximately 29 million adults in the U.S. smoke combustible cigarettes, contributing significantly to the risk of preventable deaths. Smoking and secondhand exposure are top contributors to numerous health issues, accounting for over eight million deaths worldwide annually, with a significant portion occurring in the U.S.
Addressing the Rise of E-Cigarette Use
In addition to traditional cigarette smoking, about 17 million adults in the U.S. have turned to e-cigarettes or vaping. Notably, recent surveys indicate that around 1.6 million middle and high school students reported using e-cigarettes, a trend that necessitates approved treatment options for nicotine dependence. Cytisinicline holds a Breakthrough Therapy designation from the FDA, underscoring its potential in this vital area of public health.
About Achieve Life Sciences
Achieve Life Sciences is fully committed to combatting the epidemic of nicotine dependence globally, with the ongoing mission to develop and commercialize cytisinicline. Their NDA submission to the FDA marks a progressive step in their journey to deliver effective solutions for smoking cessation.
Frequently Asked Questions
What is cytisinicline?
Cytisinicline is a plant-based medication under development for aiding smoking cessation and treating nicotine dependence.
Why is cytisinicline significant?
If approved, it would be the first new FDA-approved treatment for nicotine dependence in 20 years, providing new options for millions of American smokers.
What are the benefits of cytisinicline?
Clinical trials have shown cytisinicline to be effective in helping individuals achieve smoking cessation with a favorable safety profile.
What does the NDA submission mean for Achieve Life Sciences?
The NDA submission represents a major milestone in their effort to provide a new treatment for nicotine dependence, indicating progress in drug development.
How does cytisinicline work?
It interacts with brain receptors to reduce cravings and the pleasure associated with nicotine, potentially helping users overcome addiction.
