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Medical Areas: Neurology | Pediatrics/Neonatology | Psychiatry/Psychology | Family Medicine
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Focalin (dexmethylphenidate HCl)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved November 2001
Treatment Area: Attention deficit hyperactivity disorder
Focalin, a refined formulation of Ritalin (d,l-methylphenidate
HCl), has been approved by the FDA for the treatment of attention
deficit hyperactivity disorder. Whereas Ritalin contains both the d
and l isomers of methylphenidate, Focalin contains only the more
active d-isomer. Isomers are compounds that contain the same number
and type of atoms, but have different structures.
ADHD interferes with an individual's ability to regulate
activity level and behavior, and sustain focus on tasks. Symptoms
typically arise in early childhood, and some may persist into
adulthood. Treatment options for individuals with ADHD include
medication, such as psychostimulants and some antidepressants and
antihypertensives, as well as behavior therapy.
The safety and effectiveness of Focalin was demonstrated in two
double-blind, parallel-group, placebo-controlled trials. These
trials consisted of untreated or previously treated subjects ages
six to 17 years old with a DSM-IV diagnosis of ADHD. Both of the
studies included all three subtypes of ADHD - Combined Type,
Predominantly Inattentive Type, or Predominantly
Hyperactive-Impulsive Type. The primary comparison in both studies
was Focalin versus placebo.
In the first trial, Focalin (5, 10, or 20 mg/day total dose),
dl-threo-methylphenidate HCl (10, 20, or 40 mg/day total dose), and
placebo were compared. The multicenter, four-week, parallel group
study included 132 subjects. Subjects took the study medication
twice daily. Treatment was initiated with the lowest dose, and
doses could be doubled at weekly intervals up to the maximum
ADHD symptoms were evaluated using the SNAP-ADHD rating scale -
a standard behavioral assessment tool used in clinical trials.
Subjects treated with Focalin showed a statistically significant
improvement in symptom scores from baseline compared to subjects
who received placebo.
The second study, which involved 75 subjects, was a multicenter,
placebo-controlled, double-blind treatment withdrawal study in
children who were responders during a six-week, open label initial
treatment period. Subjects took study medication twice a day, with
a 3.5 to 5.5 hour interval between doses. The primary outcome was
proportion of treatment failures at the end of a two-week
withdrawal phase, which was measured by the Investigator Clinical
Global Impression - Improvement (CGI-I). Results showed that
subjects continued on Focalin experienced a statistically
significant lower rate of failure compared to those who received
Adverse events reported from Focalin clinical trials include
abdominal pain, fever, anorexia and nausea.
Focalin should not be used by patients with glaucoma, by
patients with motor tics or with a family history or diagnosis of
Tourette's syndrome, or by individuals known to be
hypersensitive to the drug.
It also should not be used during treatment with monoamine
oxidase inhibitors, or within a minimum of 14 days following
discontinuation of a monoamine oxidase inhibitor.
Mechanism of Action
Dexmethylphenidate hydrochloride is a central nervous system
stimulant. Focalin, the more pharmacologically active enantiomer of
the d- and l-enantiomers, is thought to block the reuptake of
norepinephrine and dopamine into the presynaptic neuron and
increase the release of these monoamines into the extraneuronal
space. The mode of therapeutic action in ADHD is not known. (from
Focalin Prescribing Information)
Novartis Pharma AG licensed the worldwide (excluding Canada)
marketing rights to Focalin from Celgene. According to an agreement
between Novartis Pharma AG and Novartis Pharmaceuticals, Novartis
Pharmaceuticals will market Focalin in the United States.
Please visit the Novartis web site for more information on