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Chantix fails in adolescents
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In a phase 4 study testing its effectiveness in teenagers, Chantix did not achieve sustained smoking cessation, according to Pfizer, the product’s manufacturer.
The United States and European Union had required the company to perform a postmarketing study that evaluated the efficacy and safety of Chantix (varenicline, Pfizer) for smoking cessation of teenagers aged between 12 and 17 years who are also dependent on nicotine, according to a press release.
To that end, the company had assigned 312 teenagers addicted to nicotine into two groups based on each participant’s weight. After a 2-week titration, participants weighing 55 kg or less received 0.5 mg of varenicline twice a day or 0.5 mg once a day. The teenagers who weighed 55 kg or more received 1 mg of varenicline twice a day or 0.5 mg twice a day. Twelve weeks of treatment were received, followed by a nontreatment period of 40 weeks.
The primary endpoint of a 4-week ongoing abstinence rate at weeks 9 through 12 in the varenicline vs. a placebo was not met, according to the release, which also stated the most common adverse events that occurred in at least 5% of all patients were abnormal dreams, agitation and nausea.
Full data will be reported at a later time, Pfizer stated. All of the data now go to the FDA to determine if Chantix can gain pediatric exclusivity, according to the release.
“This study makes a valuable contribution to the limited body of clinical research on pharmacotherapy smoking cessation treatments for adolescent smokers,” James Rusnak, MD, PhD, chief development officer of internal medicine for Pfizer said in the release.
Disclosure: Rusnak works for Pfizer.