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Home » Drug Information » FDA Approved Drugs » 2001
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.

Company: Celgene
Approval Status: Approved November 2001
Treatment Area: Attention deficit hyperactivity disorder

General Information

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.

Clinical Results

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 dose.

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 placebo.

Side Effects

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)

Additional 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 Focalin.