Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.22nd Century Group has received the US Food and Drug Administartion (FDA) clearance for its investigational new drug (IND) application to conduct a Phase II-B trial to evaluate a prescription based smoking cessation drug, X-22.
Subscribe to our email newsletter
X-22 comprises a kit of very low nicotine (VLN) cigarettes made from 22nd Century’s proprietary tobacco.
The X-22 therapy protocol allows patients to smoke X-22 cigarettes without restriction over the 6-week treatment period to facilitate the goal of quitting by the end of 6 weeks.
The company expects to start recruitment of the subjects in Phase II-B trial in August 2011.
The trial will evaluate quit rates of patients using X-22 cigarettes as compared to those using active control cigarettes with conventional nicotine content.
22nd Century Research and Development vice president Michael Moynihan said in addition to looking at the effect of X-22 cigarettes on initial quitting success, the study will also look at the effect on subjects’ attitude toward cigarettes and smoking behavior.