Achieve Life Sciences: Cytisinicline NDA Submission Expected by End of Q2 2025
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a pioneering specialty pharmaceutical company dedicated to the development and commercialization of cytisinicline as a treatment for nicotine dependence, recently reported its financial results for the fourth quarter and year-end 2024. The company also shared updates on its clinical trials and regulatory progress.
Key Milestones in ORCA-OL Trial
Achieve Life Sciences announced significant achievements in its ORCA-OL long-term exposure trial. The trial, which focuses on evaluating the safety, tolerability, and efficacy of cytisinicline for smoking cessation, reached key milestones, including:
- Completion of enrollment: The trial enrolled a total of 300 participants, ensuring a robust and diverse study population.
- Six months of cumulative treatment: All participants have now received a minimum of six months of cumulative cytisinicline treatment, as required for the submission of the NDA.
Positive DSMC Reviews
Two Data Safety Monitoring Committee (DSMC) reviews were conducted during the trial, and both demonstrated no safety concerns related to cytisinicline. This positive news reinforces the safety profile of the compound and supports its potential as a potential treatment for nicotine dependence.
New Board Members and CFO Appointments
The company also announced the appointment of Dr. Kristen Slaoui and Nancy Phelan to its Board of Directors. Dr. Slaoui brings extensive experience in corporate strategy and commercialization, while Nancy Phelan’s expertise lies in operational initiatives and financial strategy. Additionally, Mark Oki was appointed as the Chief Financial Officer to oversee the company’s financial strategy and operational initiatives.
Successful End-of-Phase 2 Meeting with FDA
Achieve Life Sciences reported a successful outcome from the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). This meeting focused on defining the development of cytisinicline as a treatment for vaping cessation. This is a significant step forward in the regulatory approval process.
How Will it Affect Me?
If you are a smoker or a vaper seeking an effective treatment for nicotine dependence, the progress of Achieve Life Sciences and cytisinicline could offer a promising solution. The successful completion of the ORCA-OL trial and the positive DSMC reviews further validate the safety and efficacy of the compound. Once approved by the FDA, cytisinicline could provide an alternative, evidence-based treatment for nicotine dependence.
How Will it Affect the World?
The potential approval of cytisinicline as a treatment for nicotine dependence could have a significant impact on global public health. According to the World Health Organization, tobacco use is the leading cause of preventable deaths worldwide. Cytisinicline, as a novel treatment, could offer a more effective and safer alternative to existing methods for smoking and vaping cessation. Moreover, the development of cytisinicline could pave the way for the creation of new, innovative treatments for nicotine dependence and other addictive behaviors.
Conclusion
In summary, Achieve Life Sciences’ progress towards the NDA submission for cytisinicline as a treatment for nicotine dependence is an essential step forward in addressing the global health issue of tobacco and nicotine addiction. The successful completion of the ORCA-OL trial, positive DSMC reviews, and the successful End-of-Phase 2 meeting with the FDA provide a strong foundation for the potential approval of cytisinicline. This breakthrough could significantly impact the lives of individuals struggling with nicotine dependence and contribute to a healthier global population.
As we eagerly await the NDA submission and potential FDA approval, the team at Achieve Life Sciences remains committed to its mission of bringing cytisinicline to market as the first new FDA-approved nicotine dependence treatment in nearly 20 years.
