Currently Enrolling Trials
Focalin (dexmethylphenidate hydrochloride) is a central nervous system (CNS) stimulant.
Focalin is specifically indicated for the treatment of Attention Deficit Hyperactivity Disorder.
Focalin is supplied as tablets and extended release tablets. The recommended dosing is as follows:
- Administer orally twice daily, 4 hours apart with or without food.
- For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily).
- For patients currently taking methylphenidate: Initiate Focalin therapy with half (1/2) the current total daily dose of methylphenidate.
- Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily).
- Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning.
- Patients currently on methylphenidate: Focalin XR dosage is half (1/2) the current total daily dosage of methylphenidate.
- Patients currently on Focalin (dexmethylphenidate) immediate-release tablets: Give the same daily dose of Focalin XR.
- Titrate weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients.
- Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg in adults.
- Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce
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.
Adverse effects associated with the use of Focalin may include, but are not limited to, the following:
- abdominal pain
- Pediatric patients 6 to 17 years:
- decreased appetite
- dry mouth
- pharyngolaryngeal pain
The Focalin drug label comes with the following Black Box Warning: CNS stimulants, including Focalin, other methylphenidatecontaining products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
Clinical Trial 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.