Plain Language Summary
What is this summary about?
This is a plain language summary of 2 articles published in the Journal of Child and Adolescent Psychopharmacology. It describes a medication called serdexmethylphenidate/dexmethylphenidate, or SDX/d-MPH for short. SDX/d-MPH is marketed under the name Azstarys®. It is in capsule form taken by mouth once a day in the morning and meant for treating patients aged 6 years and older with attention-deficit/hyperactivity disorder, commonly referred to as ADHD. This summary focuses on studies that were done in children and adolescents aged 6 to 12 years with ADHD. The study results showed how SDX/d-MPH reduced the symptoms of ADHD, how fast the medication began to work and for how long it worked in the study patients, as well as the medication's safety during 1 year of treatment.
What are the key takeaways?
Two main studies were done in patients with ADHD.
The first study was conducted in a laboratory classroom, which is a simulated school classroom setting with children and adolescents aged 6 to 12 years with ADHD. The patients received either SDX/d-MPH or a placebo. The results of this study showed that the effect of SDX/d-MPH on reducing ADHD symptoms started approximately 30 minutes after taking the SDX/d-MPH capsule and lasted for approximately 13 hours. The placebo did not have this effect. The most common side effects for those taking SDX/d-MPH were headache, abdominal (belly) pain, insomnia and upper respiratory tract infection.
The second study was also done in patients aged 6 to 12 years with ADHD. The purpose was to examine how safe and tolerable SDX/d-MPH was during 1 year of treatment. In this study, no placebo was given. The findings from the second study showed that SDX/d-MPH was safe and tolerable during the 1-year treatment period, with the most common side effects being decreased appetite, upper respiratory tract Scott H. Kollins1,2, Andrea Marraffino3, Andrew J. Cutler4,5, Charles Oh6, Matthew N. Brams7, Rene Braeckman8 & Ann C. Childress9 1 Duke University School of Medicine, Durham, NC, USA; 2 Akili Interactive, Inc., Boston, MA, USA; 3 Accel Research Sites Network, Maitland, FL, USA; 4 SUNY Upstate Medical University, Syracuse, NY, USA; 5 Neuroscience Education Institute, Lakewood Ranch, FL, USA; 6 Corium LLC, Boston, MA, USA; 7 Bayou City Research, Houston, TX, USA; 8 Zevra Therapeutics Inc, Celebration, FL, USA; 9Center for Psychiatry and Behavioral Medicine, Las Vegas, NV, USA Placebo: an inactive substance that has no medication but looks exactly the same as the actual medication and is taken in exactly the same way as the study drug. Side effect: an undesirable effect of a medication. Insomnia: difficulty sleeping. Tolerable: means that a patient can endure a medication even with the some of the side effects. infection, sore throat and nose, decreased weight and irritability. This study also showed that SDX/d-MPH was effective throughout the 1-year treatment period.
What were the main conclusions?
In the first study, children with ADHD treated with SDX/d-MPH showed noticeable improvements in ADHD symptoms as early as 30 minutes after the medication was given, and those improvements lasted up to 13 hours. SDX/d-MPH was also found to be as safe as other ADHD treatments containing methylphenidate (MPH). Results of the second study showed that children with ADHD could be treated safely with SDX/d-MPH.
Clinical Trial Registration: NCT03460652 (ClinicalTrials.gov)
This is an abstract of the Plain Language Summary of Publication article.
To read the full Plain Language Summary of this article, click here to view the PDF.
Link to the original article on the first study here
Link to the original article on the second study here
Financial disclosure
Clinical research was funded by Zevra Therapeutics Inc (previously KemPharm Inc). Funding for editorial and writing assistance in the form of proofreading, copyediting, and fact-checking was provided by Corium LLC (Boston, MA, USA). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed in the original articles.
Writing disclosure
Plain language summary graphic design, writing, and editorial support were provided by Sandra Muller; Charlette Tiloke, PhD and Gautam Bijur, PhD; and Mary C. Wiggin, respectively; of Ashfield MedComms, an Inizio company, and were funded by Corium LLC. The authors had full control of this summary and provided their final approval of all content
Acknowledgments
The authors thank the patients in both studies and staff at the participating study sites.
Competing interests disclosure
A full list of authors' disclosures can be found in the original articles. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed in the original articles. Full disclosure information for the authors can be found here: https://www.liebertpub.com/doi/10.1089/cap.2021.0077 and https://www.liebertpub.com/doi/10.1089/cap.2022.0076.