Achieve Life Sciences announcs FDA granted BTD for cytisinicline

Achieve Life Sciences announced today that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation,BTD, for cytisinicline for nicotine e-cigarette, or vaping, cessation. “Since there are no FDA-approved medications specifically indicated for nicotine vaping cessation, cytisinicline has the potential to be a first-in-class treatment to address the unique challenges of the over 13 million people in the United States who vape nicotine and are struggling to overcome their addiction,” said Dr. Cindy Jacobs, Achieve’s President and Chief Medical Officer. “Our hope is that with this Breakthrough Therapy Designation and the benefit of increased communication and guidance from the FDA, we can more quickly and efficiently advance cytisinicline as the first approved pharmacotherapy for vaping cessation, not only for adults but potentially in the future for adolescents.”