Among the top 10 causes of disability worldwide, schizophrenia’s relatively low prevalence is starkly contrasted by its profound impact on functional capacity and quality of life. With the National Institute of Mental Health estimating its prevalence in the US to range between 0.25% and 0.64%, schizophrenia is a disproportionately significant contributor to the global burden of disease. While many treatment modalities focus on managing positive symptoms like delusions, hallucinations, and disorganized speech/thought patterns, the negative symptoms of apathy, asociality, anhedonia and avolition contribute to an increased risk of premature mortality for individuals with schizophrenia, with an estimated 5-10% of persons dying by suicide.

In this article we will take a look at the last schizophrenia treatment and management guidelines to see what’s changed since the American Psychiatric Association’s 2020 treatment guidelines were released, and our predictions for possible updates in future Clinical Practice Guidelines schizophrenia management following recent FDA medication approvals.

Part 1 – Current Schizophrenia Guidelines

To start, here is a listing of some of the most recent schizophrenia treatment and management guidelines published in the US:

  • Schizophrenia
    • Neuroscience Education Institute
    • Published: June 1, 2013

Part 2 – FDA Approvals Since the Most Recent Guidelines

The medications/therapies that have been approved by the FDA since the last APA Schizophrenia Clinical Guideline Published in August 2020:

LYBALVI® (olanzapine and samidorphan)

  • Alkermes, Inc.
  • FDA Approved: June 2021
  • LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of Schizophrenia and Bipolar I disorder in adults.

INVEGA HAFIRA™ (paliperidone palmitate LAI)

  • Janssen Pharmaceuticals, Inc
  • FDA Approved: August 2021
  • INVEGA HAFIRA is an every-six-month injection, it is an atypical antipsychotic indicated for the treatment of schizophrenia in adults.

IGALMI™ (dexmedetomidine)

  • BioXcel Therapeutics
  • FDA Approved: April 2021
  • IGALMI is an alpha-2 adrenergic receptor agonist indicated in adults for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.

RYKINDO® (risperidone LAI)

  • Luye Pharma
  • FDA Approved: January 2023
  • RYKINDO is a long-acting injection formulation of the approved atypical antipsychotic risperidone for the treatment of schizophrenia and bipolar I disorder in adults.

ABILIFY ASIMTUFII® (aripiprazole LAI)

  • Otsuka / Lundbeck
  • FDA Approved: January 2023
  • ABILIFY ASIMTUFII is an atypical antipsychotic indicated for the treatment of schizophrenia in adults and as maintenance monotherapy treatment of bipolar I disorder in adults.

UZEDY® (risperidone LAI)

  • Teva Pharmaceuticals
  • FDA Approved: April 2023
  • UZEDY is an extended-release injectable suspension for subcutaneous use indicated for the treatment of schizophrenia in adults.

RISVAN® (Risperidone ISM®)

  • ROVI
  • FDA Approved: March 2024
  • RISVAN is a prolonged-release injectable antipsychotic for the treatment of schizophrenia in adults.

Part 3 – Predictions

Now that we’ve covered the current available schizophrenia guidelines, the “what’s changed” and new FDA approvals since the most recent 2020 publication, we can jump into the predictions. As a reminder, this is a list of predictions focused specifically on treatment of schizophrenia and including pharmacological treatments. These predictions are not based on specific guidelines or a specific organization, but instead provide broad, high-level predictions covering potential next guideline(s) on the topic of schizophrenia, regardless of which organization produces them.

Prediction 1

  • Incorporating Recent FDA Approvals: In upcoming guidelines, it is anticipated that the newly approved therapies and treatments will be integrated into schizophrenia management in the setting of multiple recent FDA approvals.

Prediction 2

  • Promising Treatment in Clinical Trials: The FDA is set to make a decision on the approval of KarXT (xanomeline-trospium) by September 26, 2024. This treatment is poised to be the first truly innovative approach to treating schizophrenia in a decade with clinical trials showing significant reductions in both positive and negative symptoms of schizophrenia compared to a placebo. Upon approval, we foresee its inclusion in the upcoming guidelines.

Prediction 3

  • Digital Therapeutics: Boehringer Ingelheim and Click Therapeutics have been granted FDA breakthrough device designation for their schizophrenia prescription digital therapeutic, CT-155. We predict that digital therapeutics coupled with pharmacological interventions will play a significant role in future guidelines.

Prediction 4

  • Neurostimulation: Techniques such as transcranial magnetic stimulation (TMS) or deep brain stimulation (DBS) are expected to become more refined and widely utilized as adjunct treatments for schizophrenia, particularly in cases that are resistant to traditional treatments.

With expanded options on the horizon for schizophrenia management across pharmaceutical, digital, and device-based treatment modalities, this comprehensive overview details the latest schizophrenia guidelines available and highlights significant changes and FDA approvals that have occurred since their inception. Additionally, we offer our insights and predictions for what the forthcoming Guidelines on Schizophrenia may entail. Following the release of the next guideline update, we will assess the accuracy of our predictions. We aim for a perfect score of 5 out of 5.

Do you agree with our predictions? Do you think we missed anything? And is there another topic you would like to see covered in a future guideline predictions series article? Contact us today and let us know!

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