ADHD:

Indications for: FOCALIN XR

Attention deficit hyperactivity disorder.

Clinical Trials:

Pediatric Patients – Study 1

The efficacy and safety of Focalin XR was established in a randomized, double-blind, placebo-controlled, parallel-group study in 103 pediatric patients aged 6 to 17 who met DSM-IV criteria for ADHD inattentive, hyperactive-impulsive or combined inattentive/hyperactive-impulsive subtypes. 

Patients were randomly assigned to receive either a flexible-dose of Focalin XR (5 to 30mg/day) or placebo once daily for 7 weeks. The primary efficacy outcome measure was the mean change from baseline to endpoint using the DSM-IV total subscale score of the Conners ADHD/DSM-IV Scales for teachers (CADS-T), which includes the ADHD Index and the DSM-IV total subscale.

Results showed that treatment with Focalin XR achieved a statsticalliy significant treatment effect for the CADS-T total scores compared with placebo (placebo-subtracted difference, 10.64 [95% CI, 5.38-15.91]).

 

Pediatric Patients – Studies 2 and 3

In the 2 crossover studies (Studies 2 and 3), pediatric patients aged 6 to 12 years received Focalin XR 20mg or placebo. Findings showed treatment with Focalin XR achieved statistically significant treatment effect compared with placebo according to the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) rating scale total scores at all-time points after dosing in each study (0.5, 1, 3, 4, 5, 7, 9, 10, 11, and 12 hours in Study 2 and 1, 2, 4, 6, 8, 9, 10, 11, and 12 hours in the study 3). 

In an additional study, the treatment effect of Focalin XR 20mg was seen 0.5 hours after administration in patients aged 6 to 12 years with ADHD.

 

Adult Patients - Study 4

The efficacy and safety of Focalin XR was established in a randomized, double-blind, placebo-controlled, parallel-group study in 221 adult patients aged 18 to 60 who met DSM-IV criteria for ADHD inattentive, hyperactive-impulsive or combined inattentive/hyperactive-impulsive subtypes. 

Patients were randomly assigned to receive either a flexible-dose of Focalin XR (20, 30, or 40mg/day) or placebo once daily for 5 weeks. The primary efficacy outcome measure was the mean change from baseline to endpoint using the investigator-administered DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS).

Results showed that all 3 Focalin XR doses achieved a statistically significant treatment effect compared with placebo.

  • Focalin XR 20mg/day: Placebo-subtracted difference, 5.71 (95% CI, 1.64-9.78).

  • Focalin XR 30mg/day: Placebo-subtracted difference, 5.31 (95% CI, 1.18-9.44).

  • Focalin XR 40mg/day: Placebo-subtracted difference, 8.96 (95% CI, 4.83-13.08).

Adult Dosage:

Take in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. Initially 10mg once daily; may increase by 10mg weekly; max 40mg/day. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose.

Children Dosage:

<6yrs: not established. Take in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. Individualize. ≥6yrs: initially 5mg once daily; may increase by 5mg weekly; max 30mg/day. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose.

FOCALIN XR Contraindications:

During or within 14 days of MAOIs.

Boxed Warning:

Abuse and dependence.

FOCALIN XR Warnings/Precautions:

High potential for abuse and dependence; monitor. Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors of developing a manic episode prior to initiation. Consider discontinuing if new psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud's Phenomenon; monitor for digital changes. Monitor growth (esp. children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.

See Also:

FOCALIN XR Classification:

CNS stimulant.

FOCALIN XR Interactions:

See Contraindications. Hypertensive crisis with MAOIs. Avoid concomitant use with halogenated anesthetics (eg, halothane). Risk of serotonin syndrome with serotonergic drugs. May antagonize antihypertensive drugs (eg, K+-sparing or thiazide diuretics, CCBs, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists); monitor and adjust dose of antihypertensives as needed. Concomitant risperidone may increase risk of extrapyramidal symptoms; monitor.

Adverse Reactions:

Dyspepsia, dry mouth, decreased appetite, headache, anxiety, pharyngolaryngeal pain, anorexia, nausea, abdominal pain, fever; weight loss, hypertension, tachycardia, priapism.

Metabolism:

Hepatic. Dexmethylphenidate is metabolized primarily via de-esterification.

Drug Elimination:

Renal. Half-life: ~2.2 hours (tabs); 2–3 hours (XR caps).

Generic Drug Availability:

YES

How Supplied:

XR caps, tabs—100