Sepracor files NDA for norastemizole

Chiral drug specialist Sepracor has submitted a New Drug Application inthe USA for Soltara (norastemizole) 30mg capsules for the treatment of allergic rhinitis. If approved, Soltara will be the first antihistamine product that the company will self-market, although it is currently receiving royalties on sales of two other single-isomer drugs in this class, Aventis' Allegra (fexofenadine) and UCB's Xyzal (levocetirizine). The company will also add a third to this list if Schering-Plough's Clarinex (desloratadine) is approved in the USA (Marketletters passim).

Sepracor already has a US sales force in place for its Xopenox (levalbuterol) drug for asthma, but says it plans to boost the headcount from 200 to more than 900 in anticipation of the Soltara launch. At stake is a slice of the sizeable US market for prescription antihistamines, estimated to be worth $4.6 billion in 2000, according to data from IMS Health. Additionally, the company is planning what it described as an "aggressive" direct-to-consumer advertising campaign for the new product.

Sepracor's NDA for the product is based on seven large-scale allergic rhinitis trials, as well as 30 smaller clinical studies, involving 3,700 patients.