Achieve Life Sciences Takes Major Step Forward in Vaping Cessation

Advancements in Vaping Cessation Therapy

SEATTLE and VANCOUVER, British Columbia – Achieve Life Sciences, Inc. (NASDAQ: ACHV), a prominent late-stage pharmaceutical entity, is making significant strides in the realm of vaping cessation. Their recent successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) highlights a pivotal moment in the development of cytisinicline, a potential first-in-class solution aimed at nicotine dependence. The FDA's feedback endorses Achieve's strategy to pursue a Phase 3 clinical study specializing in vaping cessation.

FDA's Approval of Phase 3 Study Design

The outcome of the End-of-Phase 2 meeting aligns Achieve with the FDA on a tailored single Phase 3 study design that evaluates cytisinicline as a treatment for adults looking to quit vaping. This includes agreement on crucial metrics such as study population criteria, primary and secondary efficacy objectives, and the mechanisms for verifying vaping abstinence through biochemical measures.

Insights from the FDA Meeting

During this critical discussion, the FDA affirmed that Achieve’s planned Phase 3 trial (ORCA-V2) along with data from the previous Phase 2 ORCA-V1 trial would be sufficient for a supplemental new drug application (sNDA) dedicated to vaping cessation. The FDA also agreed that the existing safety data collected from the ongoing ORCA-OL study provides a solid foundation for future labeling related to vaping cessation.

Understanding the Vaping Crisis

In today's landscape, approximately 11 million adults in the United States are e-cigarette users, predominantly aged between 18 and 24 — many of whom have never smoked. Alarmingly, up to 60% of these users express a desire to quit, yet there are currently no FDA-approved therapeutic options available for them to do so.

The Need for Effective Solutions

“The favorable outcome of our End-of-Phase 2 meeting emphasizes our commitment to advancing cytisinicline as a groundbreaking therapy for nicotine dependence,” articulated Cindy Jacobs, M.D., Ph.D., President and Chief Medical Officer of Achieve. The expedited Breakthrough Therapy designation from the FDA has significantly aided Achieve in streamlining interactions and feedback, enhancing the program’s progress against nicotine addiction.

Design and Objectives of the Phase 3 Trial

The upcoming Phase 3 ORCA-V2 trial aims to meticulously evaluate the efficacy and safety of cytisinicline for those dependent on nicotine from e-cigarettes. Building on the groundwork laid by the previous Phase 2 ORCA-V1 trial, ORCA-V2 is designed to include a diverse participants' cohort aimed at generating comprehensive and conclusive data.

Study Characteristics

Key elements of the ORCA-V2 trial encompass:

• Population: Adults aged 18 and older who have struggled with e-cigarette addiction.
• Design: Participants will receive 3 mg of cytisinicline three times daily for 12 weeks, compared against a placebo, all while receiving behavioral support for cessation.
• Assessment Objectives: The primary goal includes measuring weekly vaping abstinence confirmed by biochemical verification. Secondary objectives will track extended periods of continuous vaping cessation, along with safety and patient-reported outcomes throughout the trial.

Achieve's Commitment and Future Outlook

Rick Stewart, Chief Executive Officer of Achieve, expressed enthusiasm about the Phase 3 program, stating, “This marks a significant milestone for us as we confidently pursue our vision to transform vaping cessation therapies. Our partnership with the FDA remains integral as we navigate this path.”

Achieve Life Sciences is focused on addressing the pressing global issue of nicotine addiction through the development of cytisinicline, and their efforts extend beyond vaping. With over 29 million adults still smoking combustible cigarettes, Achieve aims to revolutionize smoking cessation as well.

About Cytisinicline

Cytisinicline, a plant-derived alkaloid, has shown promise in treating nicotine addiction by interacting with nicotinic receptors in the brain, potentially curbing cravings and satisfaction associated with nicotine consumption. While still investigational, the positive momentum around cytisinicline is promising for future approval and market entry.

Frequently Asked Questions

What is Achieve Life Sciences focusing on?

Achieve Life Sciences is concentrating on developing cytisinicline for treating nicotine dependence, particularly in vaping cessation.

What was the significance of the recent FDA meeting?

The meeting marked a crucial step in securing FDA approval for a Phase 3 study design, indicating progress towards developing an effective vaping cessation therapy.

Who are the typical participants for the Phase 3 ORCA-V2 trial?

The trial will include adults aged 18 and older who are dependent on nicotine e-cigarettes and have previously attempted to cease vaping.

How does cytisinicline work?

Cytisinicline works by targeting nicotinic receptors in the brain to reduce cravings and the satisfaction linked with nicotine use.

What future plans does Achieve have for cytisinicline?

Achieve plans to initiate the ORCA-V2 trial in the third quarter of 2025, with ambitions of launching a comprehensive treatment for nicotine addiction.

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