The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.
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Adverse events observed among adolescent smokers in the study were comparable to those seen in adult studies.
For current non-daily cigarette smokers, there were statistically significant associations with death from lung cancer, oral cancer, circulatory death, cardiovascular death, cerebrovascular death (stroke), and chronic obstructive pulmonary disease.
Benefits of smoking cessation medications decline over the first year.
The researchers analyzed the medical records of 56,851 new users of varenicline.
The Agency believes decreasing nicotine levels could reduce the risk that future generations will become addicted to cigarettes in addition to allowing current addicts to quit.
The data showed TNP was significantly more effective vs. no medication assisted quit attempts for males (odds ratio [OR] 1.37, 95% CI: 1.02, 1.83; P=0.03) but not for females (OR 0.96, 95% CI: 0.71, 1.31; P=0.82).
Researchers examined electronic records from one regional poison center for cases of intentional bupropion ingestion between January 1, 2009 to December 31, 2015. Reports that cited IV lipid emulsion administration or death as an outcome were further evaluated.
The researchers believe that based on their findings, e-cigarette smokers may be at increased risk for bladder cancer.
Perrigo announced that the Food and Drug Administration (FDA) has approved Abbreviated New Drug Applications (ANDAs) for Nicotine Polacrilex Gum, the generic versions of GlaxoSmithKline’s Nicorette White Ice Mint Gum.