Paliperidone Palmitate for Treatment of Schizophrenia

In part 1 this video, Gus Alva, MD, Medical Director, ATP Clinical Research, Costa Mesa, California, discusses the recent FDA-approved long-acting injectable (LAI) paliperidone palmitate administered twice a year, for the treatment of schizophrenia. Dr Alva served as a study investigator in the randomized, double-blind, noninferiority Phase 3 global study, which prompted FDA approval. His long-time patient, Patrick, discusses his participation in the clinical trial and experience with paliperidone palmitate.

In the upcoming part 2, Dr Alva and Patrick discuss patient experiences and how this treatment option can impact quality of life.

Read the Transcript:

Dr Gus Alva:  I'm Gus Alva. I'm currently the Medical Director of ATP Clinical Research in Costa Mesa, California. I'm a board-certified psychiatrist specializing in neuropsychiatric issues for the past, close to, 27 years.

I've had the distinct honor and pleasure of knowing Patrick for a good length of time. Thank you for honoring me the opportunity to be here with Patrick.

Patrick:  Hi, I’m Patrick. I've been a patient of Dr. Alva's now for a long time, like he said. I'm happy to be here as well.

What led you and your colleagues to look into developing a longer-lasting LAI? Please briefly describe the study method and the most significant findings.

Dr Alva: What got us launched into the inquiry regarding a long-acting injectable that could last for 6 months is that schizophrenia is a complex and chronic brain disorder in which the symptoms and the potential for relapsing or having a recurrence of symptomatology can impact people's daily lives in a severe manner.

We also know that long-acting injectable treatments offer a plethora, a number, of advantages compared to oral medications in treating schizophrenia. This can include obviously relieving someone from having to remember to take their medicine on a daily basis.

There's lower discontinuation rates and a sustained treatment over longer periods of time.

Having had great success with a once-a-month formulation and then an every 3-month formulation, that led into the inquiry as to whether we could lengthen the timeframe in which to protect and help out our patients with schizophrenia over a time period of 6 months. That has come to fruition with [paliperidone palmitate].

How did Patrick hear about this trial and the need for participants?

Dr Alva:  For about 27 years, I've been deeply involved with investigational clinical trial work in the newer psychiatric space.

From risperidone forward, meaning 1994 forward, I've been directly involved with the development of pretty much every single medicine that has been FDA approved for schizophrenia.

We oftentimes will offer our patients the opportunity for taking part in investigational clinical trials.

Patrick is a terrific example of someone who not only learned about those studies but took advantage of them by being involved with the initial investigational clinical trial work with [a monthly paliperidone palmitate], then with [3-month treatment paliperidone palmitate], and then with [the twice yearly paliperidone palmitate].

Patrick, please, can you share your experience with them?

Patrick:  Dr Alva invited me to join the [twice yearly paliperidone palmitate] research program. I was excited about it, because I had been on the [monthly paliperidone palmitate] and [3-month treatment paliperidone palmitate], and now was going to be involved in clinical trials for the [twice yearly paliperidone palmitate]. It's like I've been full circle around the paliperidone, development.

 Is there a significant difference on this treatment option?

Patrick:  This is a better way to get my medication, because it's only a 6-month injectable form, which means that I have a lot more freedom to do things without having to worry about taking the oral dosage or to worry about missing doses or taking double doses.

Were any outcomes different than expected?

Dr Alva:  When the clinical trial results read out, there were no unpleasant surprises regarding the side effect profile with [twice yearly paliperidone palmitate]. They were very consistent with what we had seen with [monthly paliperidone palmitate] and [3-month treatment paliperidone palmitate]. The success associated with the use is a very a pleasant bit of information.

Now, this allows us as clinicians the opportunity of offering our patients the possibility of starting out with [monthly paliperidone palmitate], given once monthly. After 4 months of being on [monthly paliperidone palmitate] with the last 2 months being on the same dosing, having the opportunity to transition to an every-3-month injection cycle or once every 6 months.

The amazing thing is that the results of the 1-year randomized, double-blind, noninferiority study that was done showed that [twice yearly paliperidone palmitate] compared to [3-month treatment paliperidone palmitate] were equally good. That gives us a lot more leverage so as to be able to give patients options and make them own the driver seat and be able to decide with us as to what's the best course of action.

In the case of Patrick, he was a phenomenal pioneer in helping us figure out that this was a terrific treatment possibility. Patrick not only has been a patient that has benefited from [3-month treatment paliperidone palmitate], but he was also 1 of the participants in this noninferiority design study.

What are best practices for clinicians to introduce this treatment to their patients?

Dr Alva:  Patrick, what do you think would be a terrific situation for you to hear when being given options?

Patrick:  It's nice to hear that it's going to have benefit to patients taking the medication, that I'm going to have some direct aid to these people. It's also good to know that there's going to be better treatment options for myself as well.   

Dr Alva:  I would agree with what Patrick just made mention of. Giving people the opportunity to lead life as completely as possible is certainly something that is freed up when they're not having to worry about remembering to take their medicine on a daily basis.

That's one of the interesting things. In the past, I've told Patrick, "Hey, leave that worrying to us. Just show up, whether it be once a month, once every 3 months. Now, we have the opportunity of once every 6 months and then you can pursue the other things in your life that are meaningful to you." That could include occupational pursuits, recreational pursuits, interpersonal pursuits.

Ultimately, that's what we're trying to accomplish, a full sense of life and the freedom of not having to worry about taking one's medicines on a daily basis.

Dr Gus Alva is a Distinguished Fellow of the American Psychiatric Association and is Board Certified by the American Board of Psychiatry and Neurology and the American Board of Geriatrics. Dr Alva completed his residency training at the University of California, Irvine Medical Center in the Department of Psychiatry and Human Behavior, where he served as chief resident during his final year of residency. Dr Alva also served as an Associate professor and deputy director in the department of psychiatry at U. C. Irvine Medical Center, and currently serves as assistant professor at U.C. Riverside Medical School, Department of Neuroscience.