Andrew J. Cutler, MD, chief medical officer, Meridien Research, and an investigator on Adhansia XR™ (methylphenidate HCI) clinical studies, discusses the new FDA approval of Adlon Therapeutics Adhansia XR™ extended-release capsules Cll for the treatment of Attention-Deficit/Hyperactivity Disorder in patients 6 and older.
Andrew J. Cutler, MD attended Haverford College in Philadelphia, Pennsylvania, earning a BS in Biology. He received his MD from the University of Virginia School of Medicine, where he was also elected to the Alpha Omega Alpha (AOA) honor medical society and received the Merck Award for outstanding medical scholarship. He completed his Medical internship, Internal Medicine residency and Psychiatry residency at the University of Virginia Medical Center, where he served as Chief Resident of Psychiatric Medicine and did research on dopamine receptor pharmacology in the lab of James P Bennett, MD, PhD. Dr. Cutler then served as the first an Assistant Professor and Director of Psychiatric Medicine at the University of Chicago. He has been Board Certified in both Internal Medicine and Psychiatry. Dr. Cutler has been Principal Investigator (PI) on over 400 psychiatric and medical clinical trials. He is the EVP and Chief Medical Officer of Meridien Research. Dr. Cutler is a Clinical Professor of Psychiatry, SUNY Upstate Medical University. Dr. Cutler has authored over 50 peer-reviewed scientific articles and has authored and presented over 100 abstracts/posters at various scientific meetings. He serves as a peer reviewer for many prestigious scientific and medical journals and serves or has served on several Editorial Boards. He has chaired or attended over 200 Scientific Advisory Boards, delivered over 3,000 pharmaceutical promotional talks and over 250 invited CME lectures and Grand Rounds presentations. He has also done over 30 national satellite television medical education broadcasts and over 100 national medical web conferences.
Neal Howard: Hello and good morning. My name is Neal Howard, your host here on Health Professional Radio, glad that you could join us again. Our guest is Dr. Andrew Cutler. He is Chief Medical Officer at Meridien Research and he’s joining us on the program today to talk about some newly FDA approved treatments for ADHD. Welcome to the program Dr. Cutler.
Dr. Andrew Cutler: Good morning Neal, it’s a pleasure.
Neal: Well I did mention that you are Chief Medical Officer at Meridien research. A bit of background about yourself and talk a little bit about Meridien Research.
Dr Cutler: Sure. So I am board certified in psychiatry and I did research on dopamine receptor pharmacology which led into me doing clinical research on ADHD and I’ve been doing ADHD clinical trials for about 20 years now. I started with some of the original extended release preparations, so called ‘once a day medicines’ and I was working at a university and then I left and I started doing research privately and I started my own research clinic in Orlando, Florida. And that grew and I eventually merged with a company called Meridien Research and we have six clinics around central Florida. I have been involved with most of the newer ADHD medications and I was an investigator in the Adhansia XR™ program.
Neal: Adhansia XR™, now that’s what we’re going to talk about today. That Adhansia XR™, this is a brand new drug. Is it a different formulation of an existing compound? Talk about this for us.
Dr Cutler: Yes, of course. Well as we know, stimulants are the first line recommended treatment for ADHD in patients, really of all ages. And what stimulants break into is two groups. There is a group that we call the amphetamines and that includes medicines like Adderall and Vyvanse, people may have heard of and the other group is called methylphenidate. They’re both stimulants but they’re slightly different chemicals. Now amphetamine and methylphenidate originally were short acting and this is to hear the old stories of their child who has to go into the school nurse in the middle of the day to get their second dose. One of the big developments in our field was when extended release preparations became available, so called once a day, now in the methylphenidate sphere, we had a couple of extended release preparations but they really didn’t fulfill a need for a truly all day up to 16 hour release where we do have medicines that do that on the amphetamine side. So Adhansia XR™ is a methylphenidate that is formulated to provide extended release once a day throughout the whole day up to 16 hours and because of that, it’s really ideally suited for adults and maybe older adolescents who really have a longer day and a lot of commitments throughout the day.
Neal: So older adolescents and adults. Now so we’re talking high school, college on up to you say age 55 maybe?
Dr Cutler: Well it’s FDA approved for ages 6 and above, although it doesn’t really specify a top end although with stimulants of course, it’s very important to be careful about anyone who has any kind of cardiac or heart disease problem and so sometimes we’re a little more careful in people as they get older, say over 55 for that reason.
Neal: As other XR compounds have been working traditionally, is this an even longer, lasting compound than what we’re normally used to an excise?
Dr Cutler: Well I wouldn’t say it’s longer than some of the other XRs particularly on the amphetamine side but it has the longest lasting data for any of the methylphenidate family. The reason this is important is that most people will do well with either amphetamine or methylphenidate but as many as 30 percent of people with ADHD will preferentially respond – meaning they’ll do better with either an amphetamine or a methylphenidate – so it’s really important to have these long lasting options with both classes of medicines to make sure you can meet the needs of individual patients.
Neal: You talked about older adolescents and adults having longer days than say your elementary school, middle school children. How was that determined? Did you have mock schools, did you go through a day with a person, how did that come about? How was that determination made?
Dr Cutler: That just and lasted up to 16 hours. Well typically if we think about children, children tend to sleep longer and tend to go to bed earlier so this medicine may not be ideal for everybody. So it’s very important to know that and to individualize your treatments. But the way this medicine was studied was in actually a mock classroom environment which lasted literally 16 hours. So we bring people in on a Saturday and we do readings and assessments. We give them the medicine and then at various time points throughout the day, various hour points, you do repeat the assessments and see if the people who get the medicine perform better than those who are getting a placebo and that’s how it was determined that the medicine lasted up to 16 hours. Sixteen hours post dose, the medicine was still working better than patients who got a placebo.
Neal: When you talk about some of the effects of stimulants of this nature, a potential for abuse is pretty high. Now we just say that that’s a potential? Of course it’s greater in an adult who has control of their own functions their own day. But when it comes to a child, what do you see as far as children becoming addicted because they’re being administered to by an adult? Do they signs?
Dr Cutler: That’s a great question and first of all, it’s very important to realize that all stimulants have a what’s called a bolded box warning – a very serious warning about the potential for abuse and what we call diversion, selling your medicine or giving it to someone else and addiction so to speak, ‘dependents’ it’s really called now. What happens typically if someone is taking a medicine as prescribed, that’s not addiction or abuse. So a child taking the pill once a day as prescribed is not abuse. What happens is abuse would be if somebody takes more than they’re prescribed or requires it from someone else and takes it when it’s not prescribed for them and especially if they’re taking it to get a ‘high’ or to change how they feel but not necessarily specifically to treat their ADHD symptoms. That would be the situation when we worry.
Neal: So it would be very important to point out that just because an adult, parent, caregiver sees maybe a change in activity, symptoms – they should never ever change the prescribed amount based on their own determination.
Dr Cutler: Not without discussing it with your prescriber or your doctor or other prescriber. That’s critically important and you really shouldn’t stop or change the dose without discussing it. It’s critically important, I agree.
Neal: What about building a tolerance to the drug? Is that something that happens in adults as well as children, you build a tolerance? Now you have to take a higher dose and now you can’t back off of that dose?
Dr Cutler: Yeah, that’s a very sophisticated point. What does tend to happen after weeks to months on a medication, a stimulant medication, is it does appear the body adjusts and it sort of doesn’t work quite as well. You can call it ‘tolerance’ and often we have to go up one notch in the dose. It’s a one time thing. it’s not like you have to continue chasing your tail and raising the dose forever, it tends to be a one time thing. But you’re absolutely right, I tell parents this all the time. If they’re taking a medicine and I have done that, I have gone up. Please don’t stop and then restart at the higher dose. Sometimes of course parents will stop the medicine over the summer and then they have this bottle of the higher dose lying around and then they may restarted when the school year starts and that’s a problem because now your body has readjusted back to the lower dose. So again, it’s very important to always discuss any changes, stopping, starting, raising dose with your healthcare provider. And again, I want to remind people that for children and maybe younger adolescents, Adhansia XR™ may not be an appropriate medicine. Now the FDA now is requiring makers of all stimulants to study their medications in children including more recently preschool age 4 and 5 year old children. In the past, our medicines were mostly studied and approved for ages 6 and above but what the FDA realized is medications are being prescribed increasingly to younger children including those under six and so they wanted to get more safety data on these medications.
Neal: Well where can our listeners go and get some more information about your firm as well as Meridian research and Adhansia XR™ as well?
Dr Cutler: Well thanks so much for asking about that. We are always doing clinical trials and looking for patients, people who may be interested in volunteering for a study. We’re doing studies for ADHD, really of all ages, ages 4 and above and our website is meridienresearch.net so we have a little bit unusual there. And then for Adhansia XR™, the company is called Adlon Therapeutics, Division of Purdue and you can go to adhansiaxr.com
Neal: Dr. Cutler, thank you so much for joining us here on Health Professional radio. It’s been a pleasure.
Dr Cutler: Thank you Neal.
Neal: You’ve been listening to Health Professional Radio. I’m your host Neal Howard, in conversation with Dr. Andrew Cutler, Chief Medical Officer at Meridien Research. Transcripts and audio of this program are available at hpr.fm and healthprofessionalradio.com.au