Merck Maxalt migraine therapy NDA filing is imminent, company indicates.
Executive Summary
MERCK MAXALT NDA FILING FOR MIGRAINE TREATMENT PLANNED BY END OF JUNE, the company indicated. The NDA for Maxalt (rizatriptan) will encompass two dosage forms and two doses of Maxalt: 5 mg and 10 mg doses in a tablet formulation and a Rapidisc "wafer that disintegrates in the mouth" using R.P. Scherer's Zydis technology. The wafer offers a convenience benefit, Merck said; the company believes the two dosage forms are comparable. The 10 mg dose will "be recommended as the primary dose," Merck said.