General Information

Azstarys (serdexmethylphenidate and dexmethylphenidate) is a central nervous system (CNS) stimulant.

Azstarys is specifically indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

Azstarys is supplied as a capsule for oral administration. The recommended dose regimen(s) is as follows:

Pediatric Patients 6 to 12 years of age

The recommended starting dosage of Azstarys is 39.2 mg serdexmethylphenidate/ 7.8 mg dexmethylphenidate once daily in the morning. The dosage may be increased after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day, or decreased after one week to a dosage of 26.1 mg serdexmethylphenidate/5.2 mg dexmethylphenidate per day, depending on response and tolerability. The maximum recommended dosage is 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate once daily.

Adults and Pediatric Patients 13 to 17 years of age

The recommended starting dosage of Azstarys is 39.2 mg serdexmethylphenidate/ 7.8 mg dexmethylphenidate once daily in the morning. Increase the dosage after one week to a dosage of 52.3 mg serdexmethylphenidate/ 10.4 mg dexmethylphenidate per day. The maximum recommended dosage is 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate once daily.

Side Effects

Adverse effects associated with the use of Azstarys 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

The Azstarys drug label comes with the following Black Box Warning: CNS stimulants, including Azstarys, other methylphenidate-containing 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 FDA approval of Azstarys was based on the following studies:

Pediatric Patients 6 to 12 years of age with ADHD

The efficacy of Azstarys for the treatment of ADHD in pediatric patients 6 to 12 years of age was evaluated in a randomized, double-blind, placebo-controlled, parallel group, analog classroom study. The study was conducted in 150 pediatric patients 6 to 12 years of age who met Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). Following washout of previous ADHD medication, subjects entered an open-label dose-optimization period (3 weeks) with an initial dosage of 39.2 mg/7.8 mg once daily in the morning. The dose could be titrated on a weekly basis to either 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg, until an optimal dose or the maximum dosage of 52.3 mg/10.4 mg/day was reached. At the end of optimization period, subjects were randomly assigned into a 1-week parallel group treatment period to receive either the individually optimized dose of Azstarys (mean dose of 45.6 mg/9.0 mg) or placebo. At the end of the 1-week treatment period, raters evaluated the attention and behavior of the subjects in a laboratory classroom setting over a period of 13 hours using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. The primary efficacy endpoint was the mean change from baseline (pre-dose at randomization visit) of the SKAMP-Combined scores averaged across the test day (not including baseline score), with assessments conducted at 0.5, 1, 2, 4, 8, 10, 12, and 13 hours post-dose. The mean change from baseline in the SKAMP-Combined scores, averaged across the test day, was statistically significantly lower (indicating improvement) with Azstarys compared to placebo.

Adults and Pediatric Patients 13 to 17 years of age with ADHD

The efficacy of 52.3 mg/10.4 mg Azstarys in adults and pediatric patients 13 to 17 years of age was established by pharmacokinetic bridging between Azstarys (52.3 mg/10.4 mg) and dexmethylphenidate hydrochloride extended-release capsules.