Pfizer Inc. said its Chantix smoking-cessation treatment failed to help adolescents kick the habit in a study required by regulators.
The study did not meet its primary endpoint of the four-week continuous abstinence rate at weeks 9 through 12 when compared to placebo.
The phase 4 trial was conducted in nicotine dependent adolescents 12 to 19 years of age. It was not designed to assess the efficacy of the drug.
Chantix, approved as Champix in the EU and other countries, is approved for adults. The New York-based drug giant plans to use the data from the study to seek what is known as a pediatric exclusivity determination.
Such exclusivity, which protects the product from copycat competitors for six months, is offered as an incentive to test medicines in children.