Dr. David Walling, Ph.D., CEO, psychologist and principal investigator at CNS Trials, a clinical research provider, discusses the recent FDA approval (June 2018) of ARISTADA INITIO™ for the initiation of ARISTADA® (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults.
Dr. Walling serves as Chief Executive Officer and Principal Investigator for CNS. He has participated as a lead or co-investigator in more than 200 clinical studies, with many focusing on schizophrenia and schizoaffective disorder. Dr. Walling has authored numerous articles in leading scientific journals, including the American Journal of Psychiatry, American Journal of Psychotherapy, and Journal of Nervous and Mental Disease.
Neal Howard: Welcome to Health Professional Radio. I’m your host Neal Howard, thank you for joining us. I’m in conversation today with Dr. David Walling, the principal investigator for CNS and he’s joining us here on the program today to talk about a recently FDA-approved treatment for Schizophrenia. Welcome to the program Doctor.
Dr. David Walling: Thank you very much.
Neal: As a psychologist, explain the difference between a psychologist and a psychiatrist for those who may not be familiar.
Dr Walling: Absolutely. So a psychiatrist has gone to medical school and then done a residency in psychiatry. A psychologist has a doctoral degree in psychology and we specialize in different areas of psychology. So for example, I taught medical school for a number of years, my area background is psychopharmacology as well as Schizophrenia but a psychiatrist really, they do the prescribing and the treating for patients who have psychiatric illness. Psychologists also treat but a lot of times we do diagnose and we also do research.
Neal: Well we’re here today to talk about a recently FDA-approved treatment for as you say schizophrenia, one of your areas of expertise. What is schizophrenia?
Dr Walling: That’s a very interesting question. So Schizophrenia is a psychiatric illness that for many individuals involves symptoms that include hallucinations. So they may hear things that other people don’t hear, they may see things that other people don’t see, they may have what we call delusions so they may in a person that has paranoid delusions, they may believe that others are following them around or plotting against them. And then they also may have what we call negative symptoms of schizophrenia which is the absence of what we would consider to be normal, so they have a difficult time engaging with other people, engaging in social interactions. They may sit around and not do things and they not have motivation to get out and do things. So it’s a cluster of symptoms that we consider to be schizophrenia. Most people again are probably familiar with what they’ve seen on the movies or TV which often times is the auditory hallucinations but it’s much more than that. Auditory hallucinations, delusions, negative symptoms – all of those kind of play into the diagnosis of schizophrenia.
Neal: Is this something that’s rare?
Dr Walling: So it occurs and depending upon where you look in the world, the rates vary just a little bit but right around 1% of the population has schizophrenia so about one out of every hundred individuals. So I would not say it’s common but at the same time, it’s not rare.
Neal: The FDA has recently approved a new treatment, a long-acting treatment for schizophrenia. Are we talking different levels of schizophrenia that can be treated or is this something that is helpful across the board from those who suffer?
Dr Walling: Yes. So the long-acting treatments actually have been around for a while. They actually go back to we had in the late 80s and Haldol Decanoate, Prolixin Decanoate actually earlier than that. And then in the 2000s, we got other long-acting injectables. So what the FDA recently approved was actually a way to initiate the long-acting, much faster because a lot of times we actually had to cover an individual with oral medications until the medication was released in their system. But your question also about, is it for treating different types of schizophrenia, at this time we don’t really have medications that are designed to treat different types of schizophrenia. Our medications are kind of broad spectrum and treat individuals with schizophrenia. However, what happens is a particular medication may not work for every individual and so it’s nice to have lots of different options available and so it’s why we’re always working on new medications for schizophrenia because we really don’t know what’s going to work for one person.
Neal: Now I understand that ARISTADA INITIO™ is the first long-acting treatment for this. How is it administered?
Dr Walling: So it’s actually it’s not the only long-acting injectable for schizophrenia. However, what it is and this is really kind of a game changer is it is a way to start a long-acting injectable and get the blood levels up very quickly in individuals. So it’s the first time we have an injection that we can give along with the long-acting injection. So essentially, what happens is on Day One we give two injections and one oral medication and within just a couple of days, the blood levels get up to where they need to be to be therapeutic for an individual. Whereas in the past, we would oftentimes as either give one injection and then a week later, we give another injection or we’d have to give oral medications for up to three weeks in order to get those blood levels where they need to be. So what’s really different about this is if you have a patient in the hospital and you’re concerned about whether or not they’re going to take their medication when they leave, you can actually give those two injections in one pill and know that your patient has medication in their system for up to two months.
Neal: So prior to this FDA approval, were all patients admitted and stayed in the hospital until you were satisfied that they had enough medication in their system and then you would release them even though compliance may be an issue?
Dr Walling: Well yes.So I wish it were the case that we would be able to keep them until we were absolutely sure but the fact of the matter is the way insurance companies work and things like that, oftentimes we’re letting patients out into the community when they somewhat stabilized or their symptoms have calmed down. This is a way to actually make sure that they do have the medication in their system. And you’re right, compliance is a huge issue in this population. I mean when you look at the literature on compliance, you see somewhere between forty and eighty percent of patients with schizophrenia not taking their medication the way that is prescribed and we know that a third of prescriptions actually never get picked up at the pharmacy so compliance really is a big issue in this population.
Neal: When we were discussing long-acting injectables, how long do these injectables last?
Dr Walling: Yes. So that varies with the long-acting injectable. We have some which are as short as two weeks and some which are as long as three months. In the case of Aristada, right now there’s coverage for up to two months so ARISTADA INITIO™ you can again start in one day and for two months you know the patient has therapeutic levels in their system.
Neal: Continuity of care, it’s crucial to the patient experience and the success not only of the patient but of the of the drug itself. I mean because we are tracking the results and learning as we go, is that not correct?
Dr Walling: Absolutely. And so making sure that when you’re discharging the patient from the hospital that they have an aftercare plan that allows for them to continue to get the injections is really really important. A lot of community mental health centers are able to give injections but you have a psychiatrist in their private practice, they may not feel as comfortable giving injections.
Neal: So across the board, this is not something that a patient can be trusted to administer themselves or even someone who’s not at a high level of proficiency with these LAIs, is that correct?
Dr Walling: Well they’re actually pretty simple to give. However most patients at least in my experience, don’t want to give the injections to themselves. I mean it is either a deltoid or a gluteal injection which can be a little difficult to give to yourself so a lot of times you like a nurse doing it because they’re used to doing this all of the time or there’s actually a number of states that allow pharmacists to do it so in those states, the patient can go to the pharmacy and the pharmacist can actually give them the injection.
Neal: How about readmission rates? Obviously, you’ve got this long-acting injectable the patient can leave a hospital and live their life before they have to come back. What about the readmission for episodes using this drug? Is that something that is greatly reduced or is it reduced a little bit?
Dr Walling: Yes, so a really interesting question. I think it’s something that where we’re starting to research more and more particularly as more people are starting to use long-acting injectable. In the past and up until the recent past, the long-acting injectables were saved for those patients that were kind of seemed to have the worst symptoms of the illness and so there’s literature suggesting in some cases that these medications do prevent relapse and in others maybe it’s equivalent to oral medication if the patient is monitored in taking their oral medication daily which is a very difficult thing to do. So I think as we start to move forward and we see these medications used in more of a general population of individuals with schizophrenia, we’ll start to see more literature about the prevention of relapse bu up until recently, I mean at this point we only have about 6% of individuals with schizophrenia. So remember schizophrenia is 1% of the population then 6% of those in the U.S. getting long-acting injectables. In other countries, it’s much higher. You’ll see 30 or 40 percent of individuals with schizophrenia getting long-acting injectables.
Neal: I understand that it often manifests in early adulthood. Have you found or do you suspect that age may play a factor in the efficacy of the drug and in compliance across this population that we’re talking about here in the United States at least?
Dr Walling: So there’s two really good questions there. Let’s start with the issue of does age affect the efficacy of a medication which we actually do believe in a lot of cases. So you have younger individuals when they’re diagnosed and if you get them on medication quickly, they tend to respond really well and they go back to very close to a normal level of functioning. However, one of the issues with with your younger population is a lot of times they don’t want to accept that they have an illness and so you diagnose some with schizophrenia, you get the medication in them or stable and then they just don’t come back because they start to feel better and they don’t want to admit that they have schizophrenia to themselves really more than anybody and so keeping them on the medication is difficult. Also, taking a medication daily, taking a pill daily, is a reminder that you’re sick. So I have a lot of patients that really like getting the long-acting injectables because they’re not reminded every day that they have an Illness. Every month, every two months, every three months they come in and they get an injection and it allows them to live a much more normal life.
Neal: Well we’d like to learn some more about ARISTADA INITIO™, where can we go and learn more?
Dr Walling: Well you can certainly go, there’s a website aristadahcp.com for healthcare professionals and it contains all of the prescribing information and any information that you need may need about the efficacy of the medication.
Neal: You’ve been listening to Health Professional Radio, I’m your host Neal Howard in studio with Dr. David Walling. Thank you so much for joining us today David.
Dr Walling: Thank you.
Neal: Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm. You can subscribe to this podcast on iTunes, listen in and download at SoundCloud and be sure and visit our Affiliate Page at hpr.fm and healthprofessionalradio.com.au