Achieve Life Sciences Reports Positive Results in Clinical Trial

Achieve Life Sciences Reports on ORCA-OL Clinical Trial Outcomes

No Safety Concerns Identified by DSMC in the ORCA-OL Long-Term Exposure Trial

Achieve Reiterates Planned Cytisinicline NDA Submission in Q2 2025

SEATTLE and VANCOUVER, British Columbia — Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for smoking cessation, announced the significant findings from the long-term exposure ORCA-OL trial. The Data Safety Monitoring Committee (DSMC) recently concluded its second review of the ongoing study that evaluates cytisinicline's 3 mg treatment regimen. The trial includes individuals who smoke cigarettes or vape nicotine.

The DSMC’s second review reported no unexpected treatment-related adverse events. Participants showed excellent adherence to their prescribed cytisinicline. The safety data collected remains consistent with previous results, allowing the trial to advance as planned without the need for modifications.

CEO’s Insights on Study Progress

“The positive outcome of the DSMC’s evaluation further confirms our previous findings from Phase 2 and Phase 3 trials regarding cytisinicline's safety,” stated Cindy Jacobs, PhD, MD, President and Chief Medical Officer of Achieve. “This strengthens our confidence in the safety profile of cytisinicline, moving us closer to our planned NDA submission.”

In earlier announcements, Achieve successfully completed enrollment for the ORCA-OL trial, with 479 participants across 29 clinical sites in the U.S. A significant milestone was reached when at least 300 participants completed six months of treatment, positioning the company favorably as they approach the NDA filing.

Future Aspirations for Cytisinicline

Rick Stewart, CEO of Achieve, emphasized, “We are on track for an NDA submission for cytisinicline as a treatment for nicotine dependence. This could mark the first new prescription drug in twenty years, providing smoked tobacco users with a valuable new tool for cessation. We are committed to tackling the public health crisis posed by nicotine addiction.”

The ORCA-OL trial is primarily designed to meet the long-term exposure safety data requirements set forth by the U.S. Food and Drug Administration (FDA), making it crucial for cytisinicline’s potential approval. The FDA’s requirements include safety data from at least 300 treated participants for six months, with an additional one-year exposure from at least 100 individuals needed for the NDA approval process.

A Robust Database of Research

Since its inception, Achieve has conducted two Phase 3 clinical trials involving over 1,600 subjects seeking to quit smoking. The ongoing ORCA-OL trial is pivotal in assessing the long-term efficacy and safety of administering 3 mg cytisinicline three times daily, aimed at individuals eager to overcome nicotine dependence.

Understanding the ORCA-OL Clinical Trial

The ORCA-OL trial is an open-label design aimed at adults aged 18 and older who wish to cease smoking or vaping. Conducted across 29 clinical sites, it adheres to FDA safety data collection standards for an NDA submission requiring outcomes from 300 participants treated over six months, with longer-term data anticipated for one-year cumulative exposure.

About Achieve Life Sciences, Inc.

Achieve Life Sciences is dedicated to combating the global challenge of smoking and nicotine dependence through innovative treatments. The company has achieved success with cytisinicline in two Phase 3 trials for smoking cessation and continues to explore avenues for potential approval in vaping cessation.

Recognizing the Urgency of Cytisinicline

With approximately 29 million adults smoking combustible cigarettes, and a significant anti-tobacco movement underway, cytisinicline represents a promising avenue for assisting nicotine users. The treatment has been designated as a Breakthrough Therapy, highlighting its critical role in addressing this public health emergency.

Mechanism of Action of Cytisinicline

Cytisinicline acts as a plant-based alkaloid that interacts positively with nicotinic receptors in the brain. By alleviating nicotine craving and reducing the satisfaction associated with tobacco, cytisinicline has the potential to facilitate a safer pathway out of nicotine dependence for users both in smoking and vaping communities.

Frequently Asked Questions

What is the ORCA-OL clinical trial?

The ORCA-OL clinical trial is a study evaluating the long-term safety and efficacy of the 3 mg cytisinicline treatment for smoking cessation in adult participants.

Who is Achieve Life Sciences?

Achieve Life Sciences is a late-stage pharmaceutical company focusing on the development of cytisinicline as a cessation aid for nicotine dependence.

What were the results of the DSMC's review?

The DSMC found no unexpected treatment-related adverse events, allowing the trial to proceed without changes, emphasizing effective treatment adherence among participants.

What is cytisinicline?

Cytisinicline is a plant-derived alkaloid designed to aid in smoking and nicotine cessation by targeting nicotinic receptors in the brain.

What is the significance of the NDA submission?

The NDA submission is a critical step toward gaining FDA approval for cytisinicline as a new treatment option for nicotine dependence, marking a significant advancement in public health initiatives against smoking.

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