Achieve Life Sciences: Big Steps Towards FDA Approval of Cytisinicline
Achieve Life Sciences Reports Significant Developments and Financial Results
Achieve Life Sciences, Inc. (NASDAQ: ACHV), a specialty pharmaceutical company on a mission to develop innovative treatments for nicotine dependence through its lead product, cytisinicline, has recently revealed notable financial results for the first quarter of 2025.
In a dedication to advancing public health, Achieve has reiterated its commitment to submit a New Drug Application (NDA) for cytisinicline to the U.S. Food and Drug Administration (FDA) by June 2025. This submission is a pivotal step toward providing new options for individuals seeking to quit smoking.
CEO's Vision for Cytisinicline's Impact
Rick Stewart, the CEO of Achieve Life Sciences, emphasized the significance of this NDA submission as a culmination of relentless efforts by the Achieve team. "Cytisinicline has the potential to provide significant benefits to public health, as patients and healthcare providers actively seek new solutions to improve smoking cessation outcomes,” he stated. This aligns with current demands for new therapeutic alternatives in an area that has seen little innovation in nearly two decades.
Financial Highlights of Q1 2025
As of March 31, 2025, Achieve Life Sciences reported cash, cash equivalents, and marketable securities totaling $23.2 million. The company has incurred total operating expenses of $12.9 million in the first quarter, resulting in a net loss of $12.8 million. This indicates a focused investment in research and development aimed at bringing cytisinicline to market.
Recent Research Achievements
Recent highlights from Achieve's research further bolster its position in the smoking cessation market. Notably, results from the Phase 3 ORCA-3 trial have been published in the Journal of American Medical Association (JAMA) Internal Medicine. This trial involved 792 adults and affirmed cytisinicline’s efficacy in significantly reducing cravings and improving quitting rates.
Long-Term Safety Studies and FDA Requirements
Achieve has successfully met the FDA's long-term exposure requirements through the ongoing ORCA-OL trial. This study achieved key milestones by accumulating safety data from over 300 participants treated for six months and more than 100 participants for one year. These results highlight the tolerability of cytisinicline, positioning it as a distinctive alternative among current treatments.
Safety Monitoring and Expert Insights
The Data Safety Monitoring Committee (DSMC) conducted its third safety review of the ORCA-OL trial without raising any safety concerns, further solidifying the favorable safety profile of cytisinicline. In addition, Achieve convened a Science Advisory Board (SAB) comprised of leading experts in the field. This meeting allowed the team to discuss ongoing clinical programs and NDA preparation while gathering valuable insights from top researchers.
Commitment to Public Health and Future Directions
Achieve Life Sciences expresses strong commitment to addressing nicotine addiction through innovative therapies. Cytisinicline—a plant-based alkaloid—has demonstrated a high binding affinity to nicotinic receptors, suggesting it can effectively treat nicotine dependence by reducing cravings and withdrawal symptoms. Given that more than 29 million adults in the United States smoke, the potential impact on public health is undeniable. Cytisinicline has even been granted Breakthrough Therapy designation by the FDA, emphasizing its promise in this realm.
Looking Ahead
As Achieve Life Sciences moves towards its NDA submission, it continues to focus on safety, efficacy, and patient outcomes. The journey toward making cytisinicline an FDA-approved treatment is not just about academic success; it’s a vital step in the collective effort to reduce smoking rates and enhance overall health outcomes. With anticipation building around the upcoming submission, Achieve remains dedicated to exploring every opportunity to support individuals on their cessation journey.
Frequently Asked Questions
What is cytisinicline?
Cytisinicline is a plant-based alkaloid developed by Achieve Life Sciences aimed at treating nicotine addiction by reducing cravings and withdrawal symptoms.
When does Achieve plan to submit the NDA for cytisinicline?
Achieve Life Sciences plans to submit its New Drug Application for cytisinicline to the FDA in June 2025.
What were Achieve's financial results for the first quarter of 2025?
For the first quarter of 2025, Achieve reported a net loss of $12.8 million and total operating expenses of $12.9 million.
How many participants were involved in the ORCA-3 trial?
The ORCA-3 trial included 792 U.S. adults and focused on the efficacy of cytisinicline for smoking cessation.
What distinguishes cytisinicline from other smoking cessation aids?
Cytisinicline has shown a favorable safety profile and strong efficacy in reducing nicotine cravings, marking it as a significant innovation in smoking cessation treatments.
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