NWP06, an Extended-Release Oral Suspension of Methylphenidate, Improved Attention-Deficit/Hyperactivity Disorder Symptoms Compared with Placebo in a Laboratory Classroom Study

Abstract

ClinicalTrials.gov Identifier: NCT00904670. http://www.clinicaltrials.gov/ct2/show/NCT00904670 .

Methylphenidate and dexmethylphenidate formulations for children with attention-deficit/hyperactivity disorder

“…The onset of action of Quillivant XR ® was demonstrated at 45 minutes in the study, the first time point measured. 34 While Quillivant XR ® has been shown efficacious for a duration of 12 hours in studies against placebo, future trials need to be conducted comparing it to other available extended-release methylphenidate formulations. 34 Since Quillivant XR ® is an oral suspension, it could become the preferred methylphenidate product in children with ADHD with difficulty swallowing.…”

What's New with Stimulants?

“…They concluded that methylphenidate hydrochloride treatment effectively reduced symptoms of ADHD in children beginning at 45 minutes and continuing for 12 hours post-dose. Methylphenidate hydrochloride was also shown to be well tolerated in the study (Wigal et al, 2013).…”

“…The study, though focused on singledose pharmacokinetics and limited to a small sample size, demonstrated that methylphenidate hydrochloride had a pharmacokinetic profile similar to other extended-release preparations and was safe and well tolerated by children aged 9-15 years with ADHD. Wigal and colleagues conducted an 8-week, dose-optimized, randomized, double-blind, placebo-controlled, crossover laboratory school study of methylphenidate hydrochloride in 45 children ages 6-12 years (Wigal, Childress, Belden, & Berry, 2013). Methylphenidate hydrochloride resulted in significant (p < 0.0001) improvements in the Swanson, Kotkin, Agler, M-Flynn and Pelham Rating scale (SKAMP)-Combined score at four hours post-dose as compared with placebo in the 39 completers and significant separation from placebo occurred at each time point tested (0.75, 2, 4, 8, 10, 12 hours) (Findling, 2008).…”

Effect of Food Intake on the Pharmacokinetics of a Novel Methylphenidate Extended‐Release Oral Suspension for Attention Deficit Hyperactivity Disorder

“…MEROS is supplied as a powder that is reconstituted with water by the pharmacist prior to dispensing. On reconstitution, MEROS forms an extended‐release oral suspension of methylphenidate, available in a 25 mg per 5 mL (5 mg/mL) concentration and intended for once‐daily oral administration . According to the label, for patients ages 6 years and above, the recommended starting dose is 20 mg given orally once daily in the morning.…”

“…The formulation contains approximately 20% immediate‐release and 80% extended‐release methylphenidate. MEROS has demonstrated onset of action in 45 minutes and duration of action through 12 hours postdosing . The relative bioavailability of 60 mg of MEROS compared with 60 mg of immediate‐release methylphenidate hydrochloride (HCl) oral solution (given as 2 30‐mg doses 6 hours apart) is 95% …”