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Home » Drug Information » FDA Approved Drugs » 2012
Medical Areas: Neurology | Pediatrics/Neonatology | Psychiatry/Psychology | Family Medicine

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Quillivant XR (methylphenidate hydrochloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: NextWave Pharmaceuticals
Approval Status: Approved September 2012
Treatment Area: Attention Deficit Hyperactivity Disorder

General Information

Quillivant XR is a once daily, extended-release liquid formulation of methylphenidate HCL, a central nervous system stimulant.

Quillivant XR is specifically approved for the treatment of Attention Deficit Hyperactivity Disorder in children.

Quillivant XR is supplied as a liquid solution designed for oral administration. The recommended dose of Quillivant XR for patients 6 years and above is 20 mg orally once daily in the morning with or without food. The dose may be titrated weekly in increments of 10 mg to 20 mg. Daily doses above 60 mg have not been studied and are not recommended. Before administering the dose, vigorously shake the bottle of Quillivant XR for at least 10 seconds, to ensure that the proper dose is administered.

Clinical Results

FDA Approval
The FDA approval of Quillivant XR was based on a randomized, double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of 45 pediatrics (ages 6 to 12 years) with ADHD. There was an open-label dose optimization period (four to six weeks) with an initial 20mg dose of Quillivant XR once daily in the morning. The dose was titrated weekly in 10 or 20mg increments until an optimal dose or maximum dose of 60mg per day was reached. Subjects then entered a two-week double-blind, crossover treatment of the individually optimized dose of Quillivant XR or placebo. At the end of each week, the attention and behavior of the patients in a laboratory classroom were evaluated using the SKAMP rating scale. Quillivant XR significantly improved ADHD symptoms compared to placebo at the primary endpoint of four hours post-dose, and in a secondary analysis, showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.

Side Effects

Adverse effects associated with the use of Quillivant XR may include, but are not limited to, the following:

  • appetite decreased
  • insomnia
  • nausea
  • vomiting
  • dyspepsia
  • abdominal pain
  • weight decreased
  • anxiety
  • dizziness
  • irritability
  • affect lability
  • tachycardia
  • blood pressure increased

Mechanism of Action

Quillivant XR is a once daily, extended-release liquid formulation of methylphenidate HCL, a central nervous system stimulant. The exact mechanism of action in ADHD is unknown. The drug 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.

Literature References

Childress AC, Sallee FR, Berry SA Single-dose pharmacokinetics of NWP06, an extended-release methylphenidate suspension, in children and adolescents with ADHD. Postgraduate Medicine 2011 Sep;123(5):80-8

Additional Information

For additional information regarding Quillivant XR or ADHD, please visit the Quillivant XR web page.