FDA Panels to Meet on Risks of Pfizer’s Anti-Smoking Drug Chantix

The FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet Oct. 16 to discuss ways of treating potential risks of adverse neuropsychiatric events with Pfizer’s Chantix tablets.

Chantix (varenicline tartrate), a nicotine receptor partial agonist indicated to help patients quit smoking, was originally approved by the FDA in 2006. However, data have shown the drug increases the incidence of suicidal thoughts and depression compared with other smoking-cessation options.

In 2011, the FDA asked Pfizer to resubmit adverse event reports associated with the drug because they were not filed in a way that enables thorough evaluation. The agency also asked for a comparative postmarket trial to compare Chantix’s safety with that of other smoking cessation drugs.

The drug’s labeling currently carries a boxed warning for “serious neuropsychiatric events,” including agitation, hostility, depression, atypical changes in behavior, including suicidal ideations. — Lena Freund

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