Achieve Life Sciences announces initiation of ORCA-OL trial

Achieve Life Sciences announced it has initiated screening of subjects for the open-label ORCA-OL clinical trial. The trial is expected to provide long-term cytisinicline safety exposure data from subjects who currently smoke or use nicotine e-cigarettes and is required for submission of the cytisinicline New Drug Application, or NDA, and ultimately potential approval and marketing authorization in the United States. “We are excited to have initiated our final clinical requirement for the cytisinicline NDA and based on feedback to date, we expect the trial to enroll swiftly this year,” stated Cindy Jacobs, PhD, MD, President and Chief Medical Officer of Achieve. “Our outreach to the more than 1,100 previous study participants has yielded great interest, with roughly two-thirds expressing eagerness to participate in the upcoming trial. There are about a quarter of prior participants who are not eligible because of their continued abstinence since trial completion, which is very encouraging.”