Additionally, the most commonly reported neuropsychiatric AEs in greater than or equal to 2% of subjects were: anxiety, agitation, depression, tension, depressed mood, sleep disorders, hostility and restlessness.Regarding the secondary endpoints, there were no differences between subjects on varenicline and placebo in psychiatric scales, including the Clinical Global Impression of Improvement (CGI-I), Clinical Global Impression of Severity (CGI-S), Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (HAM-A), Barratt Impulsiveness Scale (BIS-11) and the Columbia Suicide-Severity Rating Scale (C-SSRS). Other safety endpoints were physical examination findings, vital signs and laboratory measures. “Smoking is common in psychiatric patients, including depressed patients, and it is important to have treatment options to help them quit,” said Dr. Robert Anthenelli, Professor of Psychiatry at the University of California, San Diego, Health System, VA San Diego Healthcare System, and the Principal Investigator for the study. “It’s encouraging to see that CHANTIX/CHAMPIX may be a viable option to help people with a history of depression quit smoking.” About the study The randomized, double-blind, placebo-controlled study was conducted at 38 centers in Europe and the United States. A total of 525 male and female smokers, aged 19-73 years, motivated to quit with a current or past diagnosis of MDD without psychotic features and who were either on stable antidepressant treatment or had a successfully treated episode of MDD in the past 2 years were treated for 12 weeks and followed for additional 40 weeks. Patients with a current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, or bipolar II disorder; currently using either bupropion or nortriptyline; who were at suicidal or homicidal risk or had evidence of substance abuse were not eligible to participate in the study. About CHANTIX/CHAMPIX CHANTIX was approved by the U.S. Food and Drug Administration (FDA) in May 2006 as an aid to smoking-cessation treatment in adults 18 and older, and CHAMPIX was approved by the European Medicines Agency (EMA) in September 2006.
The CHANTIX labeling can be obtained at http://labeling.pfizer.com/ShowLabeling.aspx?id=557.The EU Summary of Product Characteristics (SmPC) may be found at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000699/human_med_000696.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124. Pfizer Inc.: Working together for a healthier world ® At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.