ADHD: Strategies for Developing a Further Dialogue - Episode 10
Key opinion leaders close the discussion by considering developing medications for pediatrics with ADHD.
Tim Wilens, MD: Ann, as a researcher, you’ve been doing a lot research on new medicines or new formulations that work. Could you summarize, from a hope perspective, what’s on the landscape in the pipeline for ADHD [attention deficit hyperactivity disorder] meds?
Ann Childress, MD: If you’re looking at immediate release, there are 2 amphetamine products. One will probably be approved next month. Not with the labeling that we had hoped for with this manipulation-resistant technology, but it’s basically Evekeo [amphetamine sulfate]: manipulation-resistant pellets in a capsule that you can’t snort very well. Whatever household tools you need—apparently, they had to go through a whole bunch of them, and it’s hard to smash it up and get the drug out. There is also 1 that’s AR19, an Arbor [Pharmaceuticals, LLC] drug. The other is called Advair [fluticasone propionate, salmeterol]. It’s further behind in the pipeline, but it has this manipulation-resistant property and has done well in studies where they’re snorting and trying to liquefy it to use it IV [intravenously].
Another drug that’s going to be approved in March is KP415, and it has a component of a prodrug to serdexmethylphenidate—that’s a lot to say. It’s a prodrug of dexmethylphenidate, but it also has an immediate-release component so it starts working within 30 minutes. We did studies with it, and it still had some effect at 13 hours. The prodrug part has less abuse liability in the studies that they’ve done, but it’s got that immediate-release component. I’m not sure exactly where that’s going to end up.
They do have KP484, which is just the serdexmethylphenidate, which doesn’t have the immediate-release component. Hopefully it will wind up with some labeling that encourages people to use it and insurance companies to pay for it.
There are a couple of nonstimulants. I alluded to viloxazine, although I didn’t say its name. It was the 1 that was an antidepressant in Europe for many years. It will probably be approved in about 2 weeks. Viloxazine will be the first nonstimulant that’s come out in quite a while. It’s a serotonin norepinephrine modulating agent. It doesn’t work with the dopamine, but other than atomoxetine, it works a little on serotonin. Maybe that’s what’s helping with the depression with its antidepressant effects.
There is 1 more that’s a little further behind, centanafadine. It’s a triple reuptake inhibitor that’s going to hit dopamine, norepinephrine, and serotonin. It has been shown in phase 2 studies, in a whole bunch of adults, to beat placebo. The biggest problem I see with it is the fact that it’s a twice-a-day medicine. Anything you have to take twice a day is a nonstarter right out of the gate. We’re all encouraging them to do the work to turn it into an extended-release drug that people have to take only once a day.
I did a review paper. There are about 40 drugs in the pipeline in various places, but the ones I talked about are the ones we’ll probably see in the next year or 2.
Tim Wilens, MD: That’s really exciting just to hear that we have new potential alternatives with nonstimulants, and they’re not just me-too stimulants anymore. They are trying to make them safer. As Bob [Findling] said, you’ve got to get the medicine into people and find the best and safest way to do it.
I have to say that first, this has been an extraordinary discussion. I certainly hope you found this to be valuable to your clinical practice and learned a lot about ADHD academically. I want to thank our panelists for their views. I also want to thank all of you for watching this Psychiatric Times® and Contemporary Pediatrics® Viewpoint program. Thank you.
-Dr. Findling receives or has received research support, acted as a consultant and/or has received honoraria from Acadia, Adamas, Aevi, Afecta, Akili, Alkermes, Allergan, American Academy of Child & Adolescent Psychiatry, American Psychiatric Press, Arbor, Axsome, Daiichi-Sankyo, Emelex, Gedeon Richter, Genentech, Idorsia, Intra-Cellular Therapies, Kempharm, Luminopia, Lundbeck, MedAvante-ProPhase, Merck, MJH Life Sciences,NIH, Neurim, Otsuka, PaxMedica, PCORI, Pfizer, Physicians Postgraduate Press, Q BioMed, Receptor Life Sciences, Roche, Sage, Signant Health, Sunovion, Supernus Pharmaceuticals, Syneos, Syneurx, Takeda, Teva, Tris, and Validus.
-Dr Gephart is retired from the practice of medicine. He is on the faculty of the REACH Institute for a course entitled “Patient Centered Mental Health in Primary Care.” He receives a stipend for serving as a virtual consultant to Course graduates who call in and present difficult cases. He has no other financial contracts to report.
-Dr Childress reports receipt of research or writing support, participation on advisory boards, and service as a consultant or speaker for Adlon Therapeutics, Aevi Genomic Medicine, Akili Interactive, Allergan, Arbor Pharmaceuticals, Cingulate Therapeutics, Emalex Biosciences, Ironshore Pharmaceuticals, Jazz Pharmaceuticals, KemPharm, Lundbeck, Neos Therapeutics, Neurovance, NLS Pharma, Otsuka, Pearson, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Sunovion, Supernus Pharmaceuticals, Takeda, and Tris Pharma.
-Dr Wolraich is professor emeritus from the University of Oklahoma Health Sciences Center. He is on the steering committee and a faculty member of the REACH Institute, a non-profit organization providing CME training on mental health to primary care physicians. He has no affiliations or investments where he receives any compensation, and he is no longer in any clinical practice.
-Dr Wilens is Chief, Division of Child and Adolescent Psychiatry and Co-Director of the Center for Addiction Medicine at Massachusetts General Hospital. He receives or has received grant support from NIH(NIDA). He is or has been a consultant for Arbor, Otsuka, Ironshore, KemPharm and Vallon. He is the author of Straight Talk About Psychiatric Medications for Kids (Guilford Press). He is co-editor of ADHD in Adults and Children (Cambridge University Press), Massachusetts General Hospital Comprehensive Clinical Psychiatry (Elsevier); and Massachusetts General Hospital Psychopharmacology and Neurotherapeutics (Elsevier). He is co-owner of a copyrighted diagnostic questionnaire (Before School Functioning Questionnaire) and has a licensing agreement with Ironshore (BSFQ Questionnaire). He serves as a clinical consultant to the US National Football League (ERM Associates), U.S. Minor/Major League Baseball; Gavin Foundation and Bay Cove Human Services.