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The 52-week, Pfizer-sponsored study involved 746 participants who were randomized to receive either 12 weeks of treatment with Chantix (varenicline) or 10 weeks of treatment with NicoDerm CQ, GlaxoSmithKline's transdermal nicotine replacement therapy patch which is available over the counter (OTC). Results demonstrated that the percentage of participants who remained abstinent at six and 12 months was higher among those who received Chantix. However, the difference in abstinence rates between Chantix and NicoDerm CQ failed to achieve statistical significance: 32.4% versus 27.3%, p=0.118 at six months; 26.1% versus 20.3%, p=0.056 at 12 months. The key conclusion of the study was that abstinence from smoking was greater at the end of treatment with Chantix than with transdermal nicotine replacement therapy (55.9% versus 43.2%, p<0.001).
Since its August 2006 launch, Chantix - one of only two prescription nicotine dependence products on the market - has proved to be a key growth driver for Pfizer, achieving global sales of $883m in 2007. However, with six-month quit rates considered to be a standard measure in clinical trials and widely held to be a good predictor of long-term quit rates, Chantix's failure to demonstrate lasting superiority over a widely available transdermal nicotine replacement therapy is disappointing news for Pfizer. These results follow a sharp decline in US sales of Chantix following the drug's January 2008 label update, which warns of numerous neuro-psychiatric side effects, including suicidal behavior. Datamonitor expects that the long-term commercial potential of Chantix may have been irrevocably damaged by this year's label update.
Although the results of Chantix's head-to-head trial will not be welcome news to Pfizer, the drug's demonstrated absence of long-term superiority over an OTC treatment means that the underdeveloped prescription nicotine dependence market remains open to future players which are able to improve upon the abstinence rates and safety profiles of available treatments. In particular, Datamonitor believes that nicotine vaccines are set to make a substantial impact on the market, with their utility lying in their long-term irreversibility which is expected to reduce relapse rates. Datamonitor expects Nabi Biopharmaceuticals' NicVAX and Novartis's NIC-002 to launch in 2011 and 2012, respectively, and to achieve combined sales of over $2 billion by 2016.
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