Achieve Life Sciences Inc. (Nasdaq: ACHV) is proud to announce that the final study follow-up visit for the last subject enrolled in the Phase 3 ORCA-3 trial has occurred! This marks a significant milestone in the company’s mission to globally develop and commercialize cytisinicline for smoking cessation and nicotine dependence.
With this major step forward, Achieve Life Sciences is now one step closer to providing a safe and effective solution for those looking to break free from nicotine addiction.
We are delighted to have achieved the final milestone in the Phase 3 ORCA-3 trial and anticipate the topline data results from this trial, as well as the ORCA-V1 trial of cytisinicline as a treatment for e-cigarette cessation, to be released in the second quarter of 2021. This is a key step forward for Achieve as we continue to strive to provide innovative treatments for smoking cessation.
The ORCA-3 trial is a groundbreaking clinical study that has enrolled 792 participants across 20 locations in the United States to test the efficacy of the drug cytisinicline. Subjects received a 3mg dose of the drug three times daily for either 6 or 12 weeks, and then were monitored for a further 24 weeks.
Rigorously designed to be blinded, placebo-controlled and to provide behavioral support for the duration of the trial, the primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment. If either or both of the cytisinicline treatment arms show a statistical benefit compared to the placebo arm, the trial will be deemed a success.
If approved, Cytisinicline could become the first, non-nicotine smoking cessation prescription treatment available in the United States in nearly two decades!
The U.S. Food and Drug Administration (FDA) is currently evaluating ORCA-3, a system designed to make this life-changing treatment widely available to smokers. With ORCA-3, smokers can finally have a safe and effective way to kick the habit and start living healthier lives.
About Achieve and Cytisinicline
Achieve is determined to tackle the global smoking health and nicotine addiction epidemic by developing and bringing cytisinicline to the market. The devastating impacts of tobacco use are clear, with it being the root cause of the world’s leading preventable cause of death.
An alarming 8 million lives are lost each year due to smoking and secondhand smoke, with 87% of lung cancer deaths, 61% of pulmonary disease deaths, and 32% of coronary heart disease fatalities being attributed to it.2 It is time to take action and Achieve is committed to doing just that.
E-cigarettes, or vaping, have become increasingly popular among adults in the United States, with over 9 million people using them.3 While they may be less harmful than combustible cigarettes, they are still highly addictive and can cause lung injury or cardiovascular disease.
Unfortunately, the 2021 data shows that 1.72 million high school students are using e-cigarettes, making it the most commonly used tobacco product. Research has found that adolescents who use e-cigarettes are seven times more likely to become smokers one year later than those who have never vaped.
The FDA currently has no approved treatments specifically designed to help people quit nicotine e-cigarettes.
Cytisinicline is an exciting plant-based alkaloid that has the potential to revolutionize the way nicotine addiction is treated.
Studies have shown that this alkaloid has a high binding affinity to the nicotinic acetylcholine receptor, and could be used to reduce the severity of withdrawal symptoms and the reward and satisfaction associated with nicotine product use.
Although still in the early stages of development, Cytisinicline could soon be approved by the Food and Drug Administration for treating nicotine addiction in the United States.