AstraZeneca files for Zomig nasal spray

AstraZeneca has filed its first regulatory dossier, in Europe, for a newnasal spray formulation of its antimigraine agent Zomig (zolmitriptan) for use in treating migraine with or without aura. In addition, the firm claims it is the first to seek clearance for a second-generation triptan in nasal spray form, adding that the product is associated with an improved onset of action, high efficacy and good tolerability. Sweden will act as reference member state for pan-European approval under the mutual recognition procedure.

The triptans have not been quite the success story they were originally thought to be, although Zomig is leading the pack with 1999 sales of around $200 million. AstraZeneca has sought to boost sales with the development of a rapid-melt formulation which dissolves in the mouth, and now the nasal spray. This appears to have worked, as sales of the fast-melt formulation of the drug in Europe (it is not yet approved in the USA) helped increase Zomig sales by 34% to $178 million for the first nine months of this year (Marketletter October 30).