A joint meeting of the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee reviewed data from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) evaluating the neuropsychiatric safety of Chantix (varenicline). The Committees recommended by a majority vote to remove the boxed warning regarding serious neuropsychiatric adverse events from the Chantix labeling. The role of the Advisory Committees is to provide recommendations to the FDA; however, the FDA makes the final labeling decisions.

Earlier this year, Pfizer submitted to the FDA a supplemental New Drug Application (sNDA) requesting updates to the Chantix labeling based on the safety and efficacy outcomes of EAGLES. In addition to requesting removal of the boxed warning, Pfizer proposed retaining the Warnings and Precautions section in the labeling regarding serious neuropsychiatric events occurring in patients attempting to quit smoking and updating it with EAGLES data. Pfizer believes that such a warning would sufficiently inform prescribers of the possibility that these types of events may occur.

EAGLES is a randomized, blinded, placebo-controlled clinical trial, which was conducted by Pfizer in collaboration with GlaxoSmithKline and at the request of and designed in consultation with the FDA and the European Medicines Agency. The study is the first and largest to compare the safety and efficacy of all three currently approved smoking cessation therapies, including CHANTIX, in more than 8,000 smokers with and without a history of psychiatric disorders. It included a novel composite primary endpoint developed by Pfizer with input from the FDA, comprised of 16 components reflecting the type of events reported in the Chantix postmarketing experience and included in the labeling. Results from EAGLES were published in The Lancet in April.

“The totality of available scientific evidence, including the outcomes of EAGLES, supports the safety and efficacy of Chantix, and we look forward to the FDA’s decision on the Chantix labeling,” said Freda Lewis-Hall, M.D., DFAPA, chief medical officer and EVP, Pfizer Inc. “We are pleased with the Committees' recommendation to remove the boxed warning and believe this is an important step toward updating the Chantix labeling to more accurately reflect its neuropsychiatric safety profile and help patients and prescribers make informed decisions about treatment options.”

In the US, smoking causes more than 480,000 deaths each year and is a leading cause of preventable death and disease. Stopping smoking can have significant health benefits, reducing the risk of tobacco-related diseases such as lung cancer, heart disease, stroke, chronic respiratory disease and other conditions. While smoking rates have declined overall, some segments of society have not made the same progress. Of note, individuals with mental illness comprise a large section of the smoking population as they have a higher smoking rate than adults without mental illness (33% and 20%, respectively as reported in the 2014 National Survey). Nearly one in five adults in the US have some type of mental illness, but they smoke almost one-third of all cigarettes. Quitting is not easy and many people who want to quit struggle to do so without help.

Chantix (also known as Champix in the EU and other countries) was approved by the FDA in May 2006 as a prescription medication that, along with support, helps adults 18 and over stop smoking. Chantix is approved in more than 100 countries and has been prescribed to over 20 million patients worldwide, including more than 11 million in the US. Adults who smoke may benefit from quit-smoking support programs and/or counseling during their quit attempt. It’s possible that patients might slip up and smoke while taking Chantix/Champix. If patients slip up, they can stay on Chantix/Champix and keep trying to quit.