Medeva single isomer methylphenidate NDA expected in 1999; Apothecon licenses Medeva generic.
Executive Summary
MEDEVA/CHIROSCIENCE SINGLE ISOMER METHYLPHENIDATE NDA EXPECTED IN 1999 as part of simultaneous filings in the U.S. and Europe, Medeva told a recent meeting with securities analysts in London. Medeva and Chiroscience completed Phase I studies of the d-threo isomer of the attention deficit/hyperactivity disorder therapy methylphenidate in 1996. The companies believe the single isomer compound could have "reduced dosing and linear pharmacokinetics" compared to the racemic compound, which has "short-acting characteristics and non-linear pharmacokinetics, which make dosing and dose titration less easy and predictable," Medeva said.