Achieve Life Sciences Progresses in Cytisinicline Trial Milestone

Significant Progress in Achieve Life Sciences' ORCA-OL Trial

Achieve Life Sciences, Inc. (Nasdaq: ACHV), a company focused on developing innovative treatments for nicotine dependence, has achieved a pivotal milestone in its ongoing ORCA-OL clinical trial. This significant achievement marks the completion of at least 300 participants who have undergone a cumulative six months of cytisinicline treatment.

Long-Term Safety Data for FDA Submission

The six-month treatment data is essential for the company's New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). The FDA has emphasized the importance of long-term safety data, which is crucial given that smoking cessation medications are often used repeatedly by patients who may relapse. The completion of this milestone paves the way for Achieve Life Sciences to remain on track for its NDA submission in the upcoming quarters.

Cytisinicline's Role in Smoking Cessation

Cytisinicline, a plant-based alkaloid, acts on the brain's nicotine receptors to help mitigate symptoms of nicotine withdrawal and cravings. This innovative approach offers a promising solution for individuals struggling with smoking addiction.

Dedication to Clinical Research and Patient Support

“Reaching this milestone demonstrates our commitment to providing effective treatments for those who struggle with nicotine dependence,” stated Cindy Jacobs, Ph.D., M.D., President and Chief Medical Officer of Achieve. The support from clinical trial participants and healthcare professionals has been invaluable in moving towards this crucial goal of providing new treatments for smoking cessation.

FDA's Encouraging Feedback

Earlier discussions with the FDA affirmed their support for Achieve's NDA submission, highlighting sufficient efficacy data derived from completed Phase 3 trials, ORCA-2 and ORCA-3. These trials evaluated the effectiveness of cytisinicline over six-week and 12-week periods. The FDA also introduced a request for extended safety data beyond the six months, ensuring that comprehensive safety profiles are maintained in view of chronic usage.

Aiming for First New FDA-Approved Treatment in Two Decades

According to Rick Stewart, Chief Executive Officer of Achieve, the completion of the cumulative six-month treatment phase reflects the dedication of the research team and study participants. Achieve is committed to fulfilling all NDA-related requirements to bring cytisinicline to market as one of the first new smoking cessation treatments approved by the FDA in nearly 20 years.

Future Directions and Ongoing Trials

As part of the ongoing efforts, Achieve's ORCA-OL clinical trial is exploring the long-term safety of a three times daily dosing regimen of cytisinicline. With over 1,600 subjects enrolled in previous studies, Achieve aims to provide robust safety data to meet FDA requirements.

Addressing the Nicotine Addiction Epidemic

With around 29 million adults still smoking combustible cigarettes and an alarming number of students taking up vaping, the need for effective cessation aids is greater than ever. Cytisinicline is positioned to fill this critical gap in available treatments.

Commitment to Vaping Cessation

In addition to its smoking cessation focus, Achieve Life Sciences acknowledges the growing challenge of vaping among young people. The company plans to initiate a Phase 3 clinical study aimed specifically at addressing vaping cessation, showcasing its commitment to combating nicotine addiction in all forms.

About Achieve Life Sciences, Inc.

Achieve Life Sciences is dedicated to developing novel therapies to combat the smoking and nicotine addiction crisis worldwide. With a proven track record of successfully conducting Phase 3 studies and committed to future research, Achieve is on its way to improving the lives of countless individuals facing nicotine addiction.

Frequently Asked Questions

What is cytisinicline?

Cytisinicline is a plant-based medication designed to assist individuals in quitting smoking and vaping by reducing withdrawal symptoms and cravings.

When is the NDA submission for cytisinicline expected?

The NDA submission for cytisinicline is anticipated to occur in the second quarter of 2025.

What safety data is required for the NDA submission?

The FDA requires six-month and one-year cumulative safety data for cytisinicline to ensure its long-term safety for users.

How many participants are involved in the ORCA-OL trial?

Over 300 participants have completed the required six months of treatment in the ORCA-OL trial, which is crucial for NDA submission.

What challenges does Achieve Life Sciences face?

Achieve Life Sciences is navigating regulatory requirements and market competition while striving to bring cytisinicline to those in need of effective nicotine cessation therapies.

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