Champix label updated to include new safety and efficacy data
Posted: 24 May 2016 | | No comments yet
As part of the update, the black triangle symbol, indicating that additional safety monitoring for Champix in the UK was required, has been removed…
The European Summary of Product Characteristics (SmPC) and Package Leaflet for Pfizer’s Champix (varenicline) have been updated to include safety and efficacy data from the EAGLES trial.
Varenicline is indicated for smoking cessation in adults. As part of the update, the black triangle symbol, which indicated that additional safety monitoring for varenicline in the UK was required, has been removed.
Commenting on the news, Robert West, Professor of Health Psychology, University College London and co-author of the EAGLES study, said: “The results from EAGLES and the varenicline label update should further reassure doctors and patients about the safety and effectiveness of medicines to help smokers to stop.”
The results from the trial demonstrated that the use of varenicline or bupropion in patients with or without a history of psychiatric disorder were not associated with a significantly increased risk of serious neuropsychiatric adverse events compared with placebo. In addition, patients taking varenicline in EAGLES showed statistically superior continuous abstinence rates with varenicline at weeks 9-12 and 9-24 compared with patients treated with placebo, bupropion or nicotine (Niquitin) patch.
Dr Berkeley Phillips, UK Medical Director, Pfizer, commented: “As the largest ever smoking cessation clinical trial, EAGLES provides a significant additional body of important safety and efficacy data for varenicline and today this has been reflected in the updated European regulatory label. This further supports NICE guidance which recommends varenicline as a clinically and cost effective first line treatment option for smokers wishing to quit.”
The varenicline label update was implemented following adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency and completion of the linguistic review.