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Aristada Drug for Schizophrenia – In-Depth Doctor’s Interview

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Rakesh Amin, MD, chief medical officer for Athena Care, talks about a prescription medication that can help people with schizophrenia.

Interview conducted by Ivanhoe Broadcast News in December 2021.

Talk to me about the medication, ARISTADA. How is it different than other medications that are currently out?

DR AMIN: ARISTADA is a long-acting injectable formulation of the antipsychotic medicine aripiprazole. Unlike with oral medications, which people have to take every day, with ARISTADA, once we determine that a patient can tolerate aripiprazole, that patient can get one injection once every 4, 6 or 8 weeks, depending on the dose. In addition, patients have the option of starting treatment with ARISTADA by getting a one-time injection of ARISTADA INITIO in combination with oral aripiprazole.

Is ARISTADA more for patients who experience a severe form of schizophrenia, or, who would be the ideal patient for ARISTADA treatment?

DR AMIN: Any adult patient who is diagnosed with schizophrenia from ages 18 to 65 years old is a candidate for this long-acting injectable, ARISTADA.

Are there certain patients that wouldn’t be a good fit for ARISTADA?

DR AMIN: Patients who are allergic to aripiprazole or any of the ingredients in ARISTADA INITIO and ARISTADA should not take the medicine. In addition, elderly people with dementia-related psychosis or people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia) should not take ARISTADA.  There are patients that have other serious mental illnesses, such as substance-induced psychosis, delirium, or bipolar disorder, that are hospitalized and get treated with oral antipsychotics such as oral aripiprazole. Currently, there are no studies that indicate ARISTADA can be helpful for these indications.

For a person who has schizophrenia, what challenges can it pose on their life?

DR AMIN: Schizophrenia is a chronic mental illness that usually starts showing symptoms around the ages of 18 to 25. On average, this is an age range of people in college or people who are going straight into the workforce after high school in the United States. It’s a population of people who are trying to find their way in adulthood while also struggling with symptoms of psychosis, such as auditory hallucinations and/or visual hallucinations that can lead to paranoid delusions.

Schizophrenia can also affect one’s cognition, which can lead to different cognitive dissonance that can then lead to poorer executive functioning. This can produce an onset of what we call “negative symptoms” of schizophrenia.

There are patients with symptoms of anhedonia, where people with schizophrenia lose interest in their daily life, for example their job, hobbies, sports/activities, or hanging out with friends. They get a lot more isolated and a lot more withdrawn.

Some challenges with patients who have schizophrenia, especially the younger patients who are experiencing a “first break psychosis” (a term used in the psychiatry field of medicine), is when they start having symptoms, they lose the motivation to live their everyday lives. That could mean poor grooming, lack of showering and bathing, unbrushed teeth, skipped meals – daily mundane tasks of someone who does not experience a serious mental illness. For instance, someone with schizophrenia can be paranoid of their meals being poisoned. Or they’re getting into drug use to cope with these different symptoms of hallucinations and paranoid delusions which can lead to even more cognitive problems for these patients.

Schizophrenia can really be detrimental to a person’s brain. The most important thing is to educate those who are living with schizophrenia – patient and caregiver – about the illness and what it can portray for the longevity of their life. Yes, schizophrenia is a chronic mental illness, but it can be well-managed by patients, caregivers, and healthcare providers with an agreed upon treatment plan such as ARISTADA, a long acting injectable.

With ARISTADA, how soon can people see relief of their symptoms?

DR AMIN: Because ARISTADA is a long-acting formulation of an oral antipsychotic, we first need to start the patient on oral aripiprazole to see if it works for them and if they can tolerate it. Usually, antipsychotics work quickly and that’s why this class of medications is very effective in a chronic mental illness like schizophrenia.

It’s our hope, with titration or increase of the medications over five to seven days, maybe in the inpatient psychiatric hospitalization, we see some relief in symptoms of paranoia and hallucinations.

Once a patient is able to tolerate oral aripiprazole, then health care providers can discuss with the patient and their caregiver about a long-term treatment plan, such as the decision to transition from oral aripiprazole to a long-acting injectable like ARISTADA which comes in formulations to be given every 4, 6 or 8 weeks depending on the dose.

In terms of symptomology and the timeline of relief, when we start adding medications -specifically oral antipsychotics – we’re looking at about within a week or so.

Since Aristada is a long-acting injectable therapy, meaning patients wouldn’t have to take a pill every day, do you find that compliance might be easier?

DR AMIN: The short answer is yes.

With schizophrenia a lot of patients have poor insight into their actual illness. They do not understand this illness or what’s happening in their brain. Once health care providers treat schizophrenia patients with oral antipsychotics – whether they’re in an inpatient or outpatient setting – and they experience symptom relief, most of them will stop their medication because they think, “Hey, I’m all better now. I can go on about my life.” They’ll try to go back to their life “as it was” but inevitably another episode will take place. Once someone with schizophrenia stops taking their medication, it can lead to exacerbations of their psychosis, which turns to more pathology, or, brain chemistry changes which is detrimental to a patient’s brain over time.

Long-acting injectables, like ARISTADA, may help schizophrenia patients with adherence to medication, of course, every 4, 6 or 8 weeks depending on the appropriate course of treatment.

Taking a long-acting injectable, like ARISTADA, can also help our treatment team (health care provider, patient, and/or caregiver) communicate more effectively. For example, when a person with schizophrenia is taking an oral antipsychotic daily, their caregiver or psychiatrists may always be asking: “Are you taking your medication?”; “When did you take your medication?”; They might be checking the prescription bottle to make sure the mediation has been taken; etc. In these scenarios with daily oral antipsychotics, the patient’s autonomy can feel like it’s been taken away, but with a long-acting injectable, it can feel like there’s an extra layer of reassurance that the person is taking their medication.

In a general overview, what impact do you think ARISTADA can have on a patient’s quality of life?

DR AMIN: In my clinical experience, I think utilizing a long-acting injectable like ARISTADA can benefit my patients’ quality of life. I’ve seen young patients come into hospital settings where they’re having an acute psychotic episode and they receive a short-term injectable antipsychotic that can help them calm down and be less agitated, think a little clearer, help alleviate auditory hallucinations or visual hallucinations. But because it’s a short-term injectable antipsychotic there is no follow up or true treatment course to address the longevity of the disease.

When people with schizophrenia are treated with oral antipsychotics, they are able to get a little clearer and more educated about their illness. Once acclimated to oral antipsychotics they now have the option to discuss with their psychiatrists a transition to a long-acting injectable formulation which can be administered every 4, 6, or 8 weeks depending on the appropriate dosing. This is much easier for someone with schizophrenia to maintain versus taking a medication every day, which is very hard to do, especially for our younger population who are dealing with other aspects of life.

Are there any side effects with ARISTADA?

DR AMIN: All oral antipsychotics or all antipsychotics under that class do have side effects. The most common side effects that we do see are potentially weight gain.  Akathisia is also a common side effect that patients describe as having ants in their pants, the anxious sensation of wanting to get out of their skin or being unable to sit still (they may be pacing back and forth a lot).  These are concerning side effects that we need to address as psychiatrists and as clinicians for sure.

There is also the possibility of long-term side effects while being on an oral antipsychotic or a long-acting injectable. There could be side effects of involuntary movements, like tardive dyskinesia, which is rare, but always a possibility. Other extrapyramidal symptoms can occur, such as dystonia, which is muscle contractions. Drug-induced parkinsonism is a possibility.

Second generation antipsychotics, like aripiprazole, which ARISTADA is, like other medications in that same class, could possibly cause diabetes mellitus. It can cause glucose intolerance, which leads to diabetes. It can cause hypertension or a lipid abnormality in your labs.

All side effects are tested for and addressed every three or six months when a patient is on any antipsychotic. Labs are drawn, EKGs are done, and Ames testing are done.

When was ARISTADA FDA approved?

DR AMIN: ARISTADA was FDA approved in 2017.

What do you get asked most about when it comes to schizophrenia?

DR AMIN: In my experience as a licensed psychiatrist, I sometimes hear or see the same questions when it comes to schizophrenia. The biggest question I hear is, why are there so many readmits to a psychiatric facility or to an E.R. setting in the schizophrenia population? The second biggest question is, why aren’t more schizophrenia patients on long-acting injectables?

END OF INTERVIEW

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.

If you would like more information, please contact:

Erich Sandoval

212-867-1762

erich.sandoval@finnpartners.com

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