Fexofenadine Launched In Its First Market

1 September 1996

Hoechst Marion Roussel has launched its new nonsedating antihistamine product Allegra (fexofenadine) in the USA, its first world market. The product is indicated for the relief of the symptoms of seasonal allergic rhinitis in sufferers aged over 12.

HMR says that Allegra can provide relief of symptoms which is at least as good as other products on the market, but is safer and less prone to harmful drug interactions with other drugs which have been encountered with HMR's own Seldane (terfenadine). This carries a blackbox warning which notes that it can interact with the macrolide antibiotic erythromycin and the antifungal ketoconazole and cause cardiac side effects. US sales of Seldane fell from a peak of $600 million per year to around $400 million in 1995, largely because of these concerns.

In trials, Allegra, which is an active metabolite of terfenadine, was found to offer rapid relief of symptoms, generally within one hour of taking the dose, without sedating effects. The incidence of other adverse effects was similar to that seen with placebo, and the most common were cold or flu (2.5% versus 1.5%), nausea (1.6% v 1.5%) and menstrual pain (1.5% v 0.3%).

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