Carter-Wallace's Astelin Launched In USA

Carter-Wallace's Astelin (azelastine hydrochloride) nasal spray will belaunched onto the US market this month, following its approval by the US Food and Drug Administration in November last year. This is the first prescription antihistamine nasal spray to be introduced on the US market, says the company.

Astelin is indicated for the treatment of seasonal allergic rhinitis in adults and children over the age of 12. Prophylactic dosing with Astelin is not required and it may be used for episodes or all season long. The recommended dose is two sprays per nostril twice daily; the company did attempt to get the product approved for once-daily administration, but the FDA determined that the data submitted did not show efficacy at this dose (Marketletter November 27, 1995).

Trial Results Clinical trials with the product demonstrated that Astelin significantly improved symptoms including rhinorrhea, sneezing and nasal pruritus. Side effects were mild-to-moderate in the main, with the most frequently-reported adverse events being a bitter taste, headache, somnolence and nasal burning.