FDA Approves 2 New Products for Schizophrenia Treatment

In this video, Psych Congress Network Schizophrenia Section Editor Leslie Citrome, MD, MPH, clinical professor of psychiatry and behavior sciences, New York Medical College, Valhalla, New York, discusses 2 new therapies recently approved by the FDA for the treatment of schizophrenia. Dr Citrome provides an overview of aripiprazole monohydrate and risperidone subcutaneous injectable and explains why providers will want these options available in their clinical toolboxes.

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Read the Transcript:

Leslie Citrome, MD, MPH: Hello, I'm Dr. Leslie Citrome, clinical professor of psychiatry and behavioral sciences at New York Medical College in Valhalla, New York. I also serve as the Schizophrenia Section Editor for Psych Congress Network.

I have some exciting news to share with you. The FDA has approved two new products for the treatment of schizophrenia just last week. We're talking the last week of April 2023, two long-acting injectable treatment options are now available for our use.

The first one to be approved was actually on the 27th of April, and that is an aripiprazole monohydrate formulation that is ready to use in a prefilled syringe that can be administered every two months. It's approved for the treatment of schizophrenia, as well as a monotherapy for the treatment of bipolar maintenance. This builds upon what we have already experienced with the use of aripiprazole monohydrate once a month, and it is manufactured by Otsuka and Lundbeck. We look forward to being able to use a two-month formulation of that very same product in a somewhat easier-to-use format.

Now, the highlights for the label, when I took a look at it, was that it could be administered every two months, plus or minus two weeks. So that's an advance over the prior formulation.

The next drug to be approved was actually the very next day on April 28th, and that was Teva's product of a risperidone subcutaneous injectable product. It's a long-acting injectable that's administered not in the muscle, but underneath the skin, either the back of the arm or the abdomen. This can be administered every month or every two months.

Now, what's interesting about this formulation, that it too comes in a prefilled syringe, and it doesn't need any further preparation other than making it ready for injection by shaking it somewhat and getting it ready to put under the skin. This is a new option for subcutaneous administration of a long-acting injectable. It builds upon what we've already had experienced in the past with a one-monthly subcutaneous injectable of risperidone that was manufactured and is manufactured by another company. This provides another option for every month or every two months in a prefilled syringe. The injection volume is relatively small, and the needle gauge is actually pretty narrow as well. So I look forward to having that in my armamentarium to offer patients who are interested in a long-acting injectable, and there are many of them out there.

We look forward to more news in terms of new indications and new products as they are approved by the FDA, and watch this space on Psych Congress Network.

Leslie Citrome, MD, MPH, is clinical professor of psychiatry and behavioral sciences at New York Medical College in Valhalla, New York, and adjunct clinical professor of psychiatry, Icahn School of Medicine at Mount Sinai in New York City, New York. In addition to his academic positions, he has a private practice in psychiatry in Pomona, New York, and is a volunteer consultant to the Assertive Community Treatment team/Mental Health Association of Rockland County.