FDA Approves Methylphenidate Hydrochloride for Adult, Pediatric ADHD


The CNS stimulant was approved as an extended-released capsule intended to serve as a first-line ADHD therapy.


The US Food and Drug Administration (FDA) has approved methylphenidate hydrochloride (Adhansia XR) for the treatment of ADHD in patients aged 6 years and older.

The central nervous system (CNS) stimulant from Adlon Therapeutics—a Purdue Pharma subsidiary—was approved as an extended-released capsule intended to serve as a first-line ADHD therapy.

Its approval was based on the results of 4 clinical trials evaluating its efficacy and safety in patients with ADHD, as per American Psychiatric Association (APA) standards set by their Diagnostic and Statistic Manual of Mental Disorders, 5th Edition (DSM-5). A total of 883 patients (434 adult; 449 pediatric) were administered the methylphenidate therapy during 1- to 4-weeklong controlled treatment periods. Among the 449 pediatric patients, 156 (34.7%) were aged 6-12 years old, and 293 (65.3%) were aged 12-17 years old.

The 4 trials were comprised of 2 clinical studies in the adult patients, 1 analog classroom trial involving pediatric patients aged 6-12 years old over 13 hours, and 1 safety and efficacy trial involving pediatric patients aged 12-17 years old.

A double-blind, randomized, crossover trial evaluating methylphenidate hydrochloride versus placebo in adults with ADHD assessed its efficacy at 1, 2, 5, 8, 11, 14, and 16 hours following dosing. Investigators analyzed for a primary endpoint of mean Permanent Measure of Performance Total (PERMP-T) scores, averaged across the time points versus placebo.

Treated adults reported statistically significant improvements versus placebo, with greater mean PERMP-T scores across all time points (post-dose score 281.3 vs 254.5). For secondary endpoints of onset and duration of clinical effect—as per treatment difference in PERMP-T scores at post-dose time points—treated patients reported statistically significant improvements at post-dose hours 1, 2, 5, 8, 11, and 16 versus placebo, but not hour 14.

Investigators also reported that 10% of treated patients had discontinued therapy due to adverse reactions, compared none of the placebo-treated patients. The common causes for discontinuation were nausea, bronchitis, viral gastroenteritis, viral infection, increased blood pressure, and hypomania.

More severe adverse reactions, including sudden death, stroke, and myocardial infarction, have been previously associated with use of CNS stimulants at recommended doses. Adhansia XR will contain a boxed warning for abuse and dependence, as methylphenidate-containing products show high potential for both risks.

Purdue Pharma President and Chief Executive Officer Craig Landau, MD, acknowledged these safety risks, but adding that ADHD treated non-optimally can negatively impact various aspects of both adolescents’ and adults’ lives.

“We are committed to providing information on safe prescribing practices for this medication and initiatives to support the responsible use, storage, and disposal of all medications in this class,” he said in a statement.

Andrew J. Cutler, MD, chief medical officer of Meridien Research and an investigator in the Adhansia XR clinical trials, noted that patients tasked with balancing school and/or work as well as social activities, need longer-duration therapies to ensure they can sustain attention throughout the day.

“The approval of Adhansia XR offers a methylphenidate treatment option with a longer duration of efficacy, which may be appropriate for these patients,” Cutler said.

Purdue intends to make the therapy available on the market later this year.

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