focalin XR Approved for Treatment of ADHD

An extended release version of Focalin has just been approved for treatment of ADHD in adults, adolescents and children by the FDA. It appears the side effects seem to be similar to other stimulant medications for ADD.

From a brief look at the pdf on the site it looks like you get have the dose right away and the other half as a slow release, which is similar to Concerta and Ritalin LA.

Vincent at has more info on this.

Wikipedia page on Focalin / Dexmethylphenidate explains the how Novartis has bought the worldwide rights for Focalin and FocalinXR excluding Canada from Celgene

in exchange for milestone payments and royalties on FOCALIN and the entire Ritalin family of drugs including Ritalin, Ritalin LA, Ritalin SR and ultimately FOCALIN XR. Celgene retained the rights to FOCALIN for oncology-related indications including chemotherapy-induced cognitive dysfunction and cancer fatigue and is currently evaluating FOCALIN for this indication.

Neither Focalin nor Focalin XR is approved for sale in Canada.

Biocompare talks about the clinical trials for Focalin XR, 220 adults and 103 children and adolescents. They make it sound like there was only 2 trials before Focalin XR was approved, which sounds like a small number to me, does anyone know if there were any more trials than two?

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