Pfizer, GSK’s anti-smoking drugs not linked to increase in serious neuropsychiatric adverse events – Study
Pharma giant Pfizer’s (NYSE: PFE) smoking cessation drug Chantix (varenicline) did not show an increase in serious neuropsychiatric adverse events versus placebo and nicotine replacement therapy according to a study published in medical journal The Lancet.
Further, GlaxoSmithKline’s (LSE: GSK) Zyban (bupropion) also showed similar results according to The Lancet.
Pfizer’s chief medical officer Freda Lewis-Hall said: “Smoking is one of the leading preventable causes of death worldwide, and the benefits of quitting are immediate and substantial. These data from the Eagles study build on the large body of clinical evidence characterizing the neuropsychiatric safety and efficacy of Chantix/ Champix, which supports Chantix/Champix as an important treatment option for people who want to quit smoking.”
The Eagles trial, which was conducted by Pfizer and GlaxoSmithKline, was undertaken on the request of the US Food and Drug Administration (FDA) and the European Medicines Agency to compare the risk of clinically significant neuropsychiatric events.
According to the study, the trial did not show a significant increase in the incidence of the composite primary safety endpoint of serious neuropsychiatric adverse events with Chantix or Zyban compared to placebo and nicotine patch.
In addition, Pfizer noted that the results showed that patients with and without a history of psychiatric disorders taking Chantix had significantly higher continuous abstinence rates than patients treated with Zyban or nicotine patch during both the last four weeks of the 12-week treatment period and a 12-week non-treatment follow-up period.
In 2009, the FDA directed Pfizer and GSK to include a warning on their Chantix and Zyban about the risk of serious mental health events, including changes in behaviour, depressed mood, hostility, and suicidal thoughts.