Celgene has developed a chirally pure form of
methylphenidate (
Ritalin), called
dexmethylphenidate [d-
methylphenidate, d-
methylphenidate hydrochloride, d-MPH;
Focalin]. The
drug has been launched in the USA and is undergoing registration in Canada for the treatment of children with
attention-deficit hyperactivity disorder (
ADHD).
Dexmethylphenidate is the single isomer version of racemic
methylphenidate (
Ritalin), which contains the active d isomer of
Ritalin.
Dexmethylphenidate acts via the inhibition of reuptake of
norepinephrine and
dopamine. Research is ongoing to further clarify the mode of therapeutic action in
ADHD.
Dexmethylphenidate was developed with the aim of reducing
drug load, adverse events and drug interactions.
Dexmethylphenidate provides effective management of
attention-deficit hyperactivity disorder at half the dose of
Ritalin. In April 2000, worldwide rights (excluding Canada) to
dexmethylphenidate were granted to Novartis. Celgene has also granted Novartis rights to all related intellectual properties and patents. Novartis will fund all remaining development and marketing expenses required for regulatory approval and commercialisation of
dexmethylphenidate. Crystaal Corporation, the marketing division of Biovail Corporation International, has exclusive Canadian marketing rights for all formulations of
dexmethylphenidate. Novartis launched
dexmethylphenidate (
Focalin) in the USA during Q1 2002. It is available as a D-shaped
tablet (2.5, 5 and 10 mg doses). Novartis had planned to use the tradename Ritadex, however the FDA recommended an alternative name due to potential prescribing errors with
Ritalin. The finalized tradename to be used is
Focalin. In July 2001, a new
drug submission was filed with Canada's Therapeutic Products Programme for
dexmethylphenidate in the treatment of
attention-deficit disorder and
attention-deficit hyperactivity disorder. Novartis is also developing an extended-release version of chirally pure
dexmethylphenidate.
Dexmethylphenidate has been found to be effective and well tolerated in clinical trials, involving a total of 684 children with
ADHD and in 15 healthy adult volunteers.
Dexmethylphenidate is a schedule II
drug.